DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

NCT04752163 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2020-0946NCI-2021-00603
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial studies the effect of DS-1594b with or without azacitidine, venetoclax, or mini-HCVD in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back (recurrent) or not responded to treatment (refractory). Chemotherapy drugs, such as azacitidine, venetoclax, and mini-HCVD, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. DS-1594b may inhibit specific protein bindings that cause blood cancer. Giving DS-1594b, azacitidine, and venetoclax, or mini-HCVD may work better in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (7)

• Maximum Tolerated Dose (MTD) (Phase I)

  The highest dose of DS-1594b treatment that does not cause unacceptable side effects.

  Day 28

• Recommended Phase 2 Dose (RP2D) (Phase I)

  This will be selected based upon the cumulative safety, efficacy and PK data at the end of the Phase 1 portion when the maximum tolerated dose is found. This will be One dose level below the RP2D of DS-1594b from Phase 1.

  Day 28

• Number of Participants With Complete Remission (CR) and Complete Remission With Partial Hematologic Recover (CRh)With DS-1594b Monotherapy in (Phase II, Cohort A)

  AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods. ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

  3 months

• Number of Participants Who Achieved CR/CRh With DS-1594b Monotherapy in R/R AML With Nucleophosmin 1 Mutation (NPM1m) (Phase II, Cohort B)

  AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods.

  3 months

• Number of Participants Who Achieved CR+CRh With DS1594b in Combination With Azacitidine and Venetoclax in R/R MLLr or R/R NPM1m AML (Phase II, Cohort C)

  AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods.

  3 months

• Number of Participants Who Achieved CR+CRh With DS1594b in Combination With Mini-HCVD in R/R ALL With MLLr (Phase II, Cohort D)

  ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

  3 months

• CR+ Complete Remission With Incomplete Hematologic Recovery (CRi) Rate of DS-1594b in Combination With Mini-HCVD in R/R ALL With MLLr (Phase II Cohort D)

  ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

  3 months

Secondary Outcomes (13)

• Composite CR (CRc) Rate

  Up to 2 years

• Participants With Morphologic Leukemia-free State (MLFS)

  Up to 2 years

• Participants With a Partial Response (PR)

  Up to 2 years

• Number of Participants With a Response

  Up to 2 years

• Duration of Response

  Up to 2 years

Study Arms (8)

Cohort A and B (DS-1594b)

EXPERIMENTAL

Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Drug: DS-1594b

Cohort C (DS-1594b, venetoclax, azacitidine)

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Drug: DS-1594b; Drug: Azacitidine; Drug: Venetoclax

Cohort D (DS-1594b, mini-HCVD)

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description.

Drug: DS-1594b; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Biological: Filgrastim; Drug: Leucovorin; Drug: Mesna; Drug: Methotrexate; Drug: Prednisone; Biological: Rituximab; Drug: Vincristine

Phase I (DS-1594b) Cohort 1

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily.

Drug: DS-1594b

Phase I (DS-1594b) Cohort 2

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily.

Drug: DS-1594b

Phase I (DS-1594b) Cohort 3

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily.

Drug: DS-1594b

Phase I (DS-1594b) Cohort 4

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily.

Drug: DS-1594b

Phase I (DS-1594b) Cohort 5

EXPERIMENTAL

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily.

Drug: DS-1594b

Interventions

DS-1594b DRUG

Given DS-1594b PO

Cohort A and B (DS-1594b); Cohort C (DS-1594b, venetoclax, azacitidine); Cohort D (DS-1594b, mini-HCVD); Phase I (DS-1594b) Cohort 1; Phase I (DS-1594b) Cohort 2; Phase I (DS-1594b) Cohort 3; Phase I (DS-1594b) Cohort 4; Phase I (DS-1594b) Cohort 5

Azacitidine DRUG

Given IV or SC

Also known as: 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, Onureg, U-18496, Vidaza

Cohort C (DS-1594b, venetoclax, azacitidine)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Cohort D (DS-1594b, mini-HCVD)

Cytarabine DRUG

Given IT

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

Cohort D (DS-1594b, mini-HCVD)

Dexamethasone DRUG

Given PO or IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Cohort D (DS-1594b, mini-HCVD)

Filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tevagrastim

Cohort D (DS-1594b, mini-HCVD)

Leucovorin DRUG

Given IV or PO

Also known as: Folinic acid

Cohort D (DS-1594b, mini-HCVD)

Mesna DRUG

Given IV

Also known as: 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna, Mercaptoethane Sulfonate, Mercaptoethanesulfonate, Mesnex, Mesnil, Mesnum, Mexan, Mistabron, Mistabronco, Mitexan, Mucofluid, Mucolene, UCB 3983, Uromitexan, Ziken

Cohort D (DS-1594b, mini-HCVD)

Methotrexate DRUG

Given IT

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Cohort D (DS-1594b, mini-HCVD)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Cohort D (DS-1594b, mini-HCVD)

Rituximab BIOLOGICAL

Given IV

Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima

Cohort D (DS-1594b, mini-HCVD)

Venetoclax DRUG

Given PO

Also known as: ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto

Cohort C (DS-1594b, venetoclax, azacitidine)

Vincristine DRUG

Given IV

Also known as: Leurocristine, VCR, Vincrystine

Cohort D (DS-1594b, mini-HCVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written (signed) informed consent form (ICF) by the subject or legal guardian prior to the performance of any study-specific procedures, according to International Council on Harmonisation (ICH) and local regulatory requirements. Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible toxicities) and must sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF)(including Health Insurance Portability and Accountability Act authorization \[HIPAA\], if applicable) before performance of any study-specific procedures or examinations
• Subjects must be willing and able to comply with the protocol
• Subjects with AML or ALL, diagnosed according to the 2016 criteria by the World Health Organization (WHO) who are refractory or relapsed (any salvage) with no available therapies or not candidates for available therapies. For subjects with prior MDS or chronic myelomonocytic leukemia (CMML) or MPN who transformed to AML, therapy received for MDS, CMML, or MPN is NOT considered as prior therapy for AML except for MDS or CMML treated with HMAs. Subjects with MDS or CMML treated with HMA therapies who progress to AML and have no available therapies or are not candidates for available therapies, will be eligible at the time of progression to AML. In Phase 1: all R/R AML or R/R ALL subjects irrespective of mutations will be eligible. In Phase 2 Cohort A only R/R AML with MLLr will be eligible. In Phase 2 Cohort B only R/R AML with NPM1m will be eligible. In Phase 2 Cohorts C and D: Only R/R AML or R/R ALL subjects with an MLLr or NPM1m will be eligible
• Prior therapy with hydroxyurea, chemotherapy, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is permitted
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Total bilirubin =\< 1.5 times upper limit of normal (x ULN)
• Aspartate aminotransferase or alanine aminotransferase =\< 2.5 x ULN (aspartate aminotransferase or alanine aminotransferase =\< 5.0 x ULN if deemed related to leukemia by the treating physician)
• Creatinine clearance \>= 50 mL/min as calculated using the modified Cockcroft-Gault equation
• Serum electrolytes within the institution's normal limits: potassium, calcium (total calcium, calcium corrected for serum albumin in case of hypoalbuminemia or ionized calcium) and magnesium. If outside of the institution's normal range, subject will be eligible when electrolytes are corrected
• In the absence of rapidly progressive disease, the interval from prior treatment to the time of initiation of protocol therapy will be at least 14 days for prior anti-leukemic therapy with the exception of hydroxyurea as noted below OR at least 5 half-lives for cytotoxic/noncytotoxic agents, whichever is shorter. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document. Since the effect of therapy may be delayed, use of hydroxyurea for subjects with rapidly proliferative disease is allowed before the start of study therapy and on study and hydroxyurea will not require a washout
• Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted. Subjects with a known history of CNS disease or leukemic brain metastasis must have been treated locally, have at least 3 consecutive lumbar punctures (LPs) with no evidence of CNS leukemia, and must be clinically stable for at least 4 weeks prior to enrollment and have no ongoing neurological symptoms that in the opinion of the treating physician are related to the CNS disease (sequelae that are a consequence of the treatment of the CNS disease are acceptable)
• Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
• Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include:
• Total abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.

You may not qualify if:

• Subjects with a known allergy, hypersensitivity, or contraindication to the protocol therapies or any of their components to be used in the arm the subject is to be enrolled on
• Uncontrolled or significant cardiovascular disease, including any of the following:
• Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
• Corrected QT interval Fridericia's Correction Formula (QTcF) interval \> 450 msec;
• Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
• Systolic blood pressure \>=180 mmHg or diastolic blood pressure \>=110 mmHg;
• History of clinically relevant ventricular arrhythmias within 6 months prior to screening (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
• History of second (Mobitz II) or third-degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
• History of uncontrolled angina pectoris, unstable angina or myocardial infarction, coronary artery bypass graft (CABG), cerebrovascular accident (CVA), transient ischemia attack (TIA), symptomatic pulmonary emboli within 6 months prior to screening;
• New York Heart Association Class 3 or 4 heart failure;
• Left ventricular ejection fraction (LVEF) =\< 50 or less than the institutional lower limit of normal;
• Complete left bundle branch block (right bundle branch block is permitted, but requires manual reading of the QTc interval);
• Active cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \>= 2 (eg, atrial fibrillation)
• Persisting toxicity related to prior therapy of grade \> 1 NCI-CTCAE v 5.0; however, alopecia and sensory neuropathy grade 2 or lower is acceptable
• Underwent HSCT within 90 days of the first dose of protocol therapy, or subjects with clinically significant (grade 2 or greater) graft-versus-host disease (GVHD) (the use of topical steroids for ongoing cutaneous GVHD is permitted)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Numata M, Haginoya N, Shiroishi M, Hirata T, Sato-Otsubo A, Yoshikawa K, Takata Y, Nagase R, Kashimoto Y, Suzuki M, Schulte N, Polier G, Kurimoto A, Tomoe Y, Toyota A, Yoneyama T, Imai E, Watanabe K, Hamada T, Kanada R, Watanabe J, Kagoshima Y, Tokumaru E, Murata K, Baba T, Shinozaki T, Ohtsuka M, Goto K, Karibe T, Deguchi T, Gocho Y, Yoshida M, Tomizawa D, Kato M, Tsutsumi S, Kitagawa M, Abe Y. A novel Menin-MLL1 inhibitor, DS-1594a, prevents the progression of acute leukemia with rearranged MLL1 or mutated NPM1. Cancer Cell Int. 2023 Feb 25;23(1):36. doi: 10.1186/s12935-023-02877-y.

  PMID: 36841758 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes

Interventions

Azacitidine; Cyclophosphamide; Cytarabine; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Filgrastim; Granulocyte Colony-Stimulating Factor; Leucovorin; Mesna; Methotrexate; merphos; Prednisone; deltacortene; prednylidene; Rituximab; CT-P10; venetoclax; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Arabinonucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Aminopterin; Pregnadienediols; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Results Point of Contact

• Title: Naval Daver MD./Professor
• Organization: The University of MD Anderson Cancer Center

NDaver@mdanderson.org

713-794-4392

Study Officials

• Naval G Daver, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 12, 2021
• Study Start: March 25, 2021
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Locations

US (1)