Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

NCT03856216 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2018-0860NCI-2019-00531
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.

Conditions

Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; Lymphocytic Neoplasm; Lymphoma

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant.

  VOD (veno-occlusive disease) is a severe liver injury caused by chemotherapy drugs and it is usually presents with abdominal pain and swelling, with evidence of portal hypertension and variable degrees of serum enzyme elevations and jaundice.

  Up to 45 days post transplant

Secondary Outcomes (2)

• Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant.

  Up to 1 year post transplant.

• Progression-free Survival (PFS)

  Up to 3 years

Study Arms (2)

Group I (inotuzumab ozogamicin, chemotherapy, transplant)

EXPERIMENTAL

Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.

Procedure: Allogeneic Bone Marrow Transplantation; Biological: Filgrastim-sndz; Drug: Fludarabine; Biological: Inotuzumab Ozogamicin; Drug: Melphalan; Procedure: Peripheral Blood Stem Cell Transplantation; Biological: Rituximab; Drug: Tacrolimus

Group II (inotuzumab ozogamicin, chemotherapy, transplant)

EXPERIMENTAL

Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.

Procedure: Allogeneic Bone Marrow Transplantation; Drug: Bendamustine; Biological: Filgrastim-sndz; Drug: Fludarabine; Biological: Inotuzumab Ozogamicin; Procedure: Peripheral Blood Stem Cell Transplantation; Biological: Rituximab; Drug: Tacrolimus

Interventions

Allogeneic Bone Marrow Transplantation PROCEDURE

Given IV

Also known as: Allo BMT, Allogeneic Blood and Marrow Transplantation, Allogeneic BMT

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Bendamustine DRUG

Given IV

Also known as: SDX-105

Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Filgrastim-sndz BIOLOGICAL

Given IV

Also known as: Filgrastim Biosimilar Filgrastim-sndz, Zarxio

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Fludarabine DRUG

Given IV

Also known as: Fluradosa

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Inotuzumab Ozogamicin BIOLOGICAL

Given IV

Also known as: Besponsa, CMC-544, Way 207294, WAY-207294

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Melphalan DRUG

Given IV

Also known as: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813

Group I (inotuzumab ozogamicin, chemotherapy, transplant)

Peripheral Blood Stem Cell Transplantation PROCEDURE

Given IV

Also known as: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

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

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Tacrolimus DRUG

Given IV and PO

Also known as: FK 506, Fujimycin, Hecoria, Prograf, Protopic

Group I (inotuzumab ozogamicin, chemotherapy, transplant); Group II (inotuzumab ozogamicin, chemotherapy, transplant)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants age 12 to 75.
• English and non-English speaking participants are eligible.
• CD22+ lymphoid malignancies including B-ALL
• Eligible to receive a reduced-intensity alloSCT
• Participants with:
• Indolent lymphoma participants who failed conventional treatment; or,
• Acute lymphoblastic leukemia (ALL), aggressive lymphoma, indolent lymphoma in transformation, or those who have failed ≥ three small molecule inhibitors
• Donor: HLA compatible (8/8 match) related or matched unrelated donor (HLA-A, B, C, DRB1) or mismatched MUD (7/8 match) or haploidentical
• Performance status of 0 to 2, Lansky ≥ 80 for \< 16 years and Karnofsky ≥ 80 for ≥ 16 years of age.
• Adequate organ function at time of study entry
• Creatinine less than or equal to 1.6 mg/dL
• Bilirubin less than 1.6 mg/dL
• SGPT \< 2 x UL
• Ejection fraction \>/= 40%
• FEV1, FVC and cDLCO \>/= 40%

You may not qualify if:

• Human immunodeficiency virus (HIV) positive.
• Prior autologous transplant less than 1 year prior to consent.
• Active and uncontrolled disease/infection.
• Unable or unwilling to sign consent.
• Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
• Active hepatitis B or C.
• Recent systemic chemotherapy or radiation within 3 weeks of study entry (intrathecal therapy is allowed).
• Standard biological agents such as rituximab, TKIs such as ibrutinib and venetoclax are allowed to be given within 3 days prior to receiving inotuzumab ozogamicin. Blinatumomab is allowed to be given until 1 week prior to Day -13 inotuzumab ozogamicin on study.
• Prior inotuzumab ozogamicin within 3 weeks of study entry.
• Peripheral blast count of greater than 10 K/mL.
• QTcF interval \> 470 ms.
• Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Lymphoma

Interventions

Bone Marrow Transplantation; Bendamustine Hydrochloride; Filgrastim; Granulocyte Colony-Stimulating Factor; fludarabine; Inotuzumab Ozogamicin; Melphalan; Peripheral Blood Stem Cell Transplantation; Rituximab; CT-P10; Tacrolimus

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic 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; Calicheamicins; Aminoglycosides; Glycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Antibodies, Monoclonal, Murine-Derived; Macrolides; Lactones

Results Point of Contact

• Title: Issa F. Khouri, MD/Stem cell transplantation department
• Organization: UT MD Anderson Cancer Center

ikhouri@mdanderson.org

713-745-0049

Study Officials

• Issa F Khouri

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 27, 2019
• Study Start: October 28, 2019
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-03

Locations

US (1)