Nonmyeloablative Haploidentical Transplant Followed by MLN9708

NCT02169791 | Completed Phase 2 Results

• 2 other identifiers: NSH 1074X16035
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

In an attempt to reduce relapse risk and improve outcomes following haploidentical transplantation for patients with high risk hematologic malignancies, the investigators will implement several strategies to augment the well documented effect of NK cell alloreactivity seen in HLA-mismatched transplantation. These strategies include (1) choosing potential haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the post-transplant immunosuppression regimen to improve NK cell reconstitution following haploidentical peripheral blood stem cell transplantation.

Conditions

Acute Leukemia; Chronic Leukemia; Myelodysplastic Syndrome; Lymphomas; Multiple Myeloma

Keywords

hematologic malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Relapse or Progression

  To estimate the incidence of relapse/progression at one-year post-transplant.

  1 year

Secondary Outcomes (5)

• Neutrophil Engraftment

  1 year

• Time to Platelet Recovery Post Transplant

  1 year

• Day 30 CD3 Donor Chimerism

  30 days

• Day 30 CD33 Donor Chimerism

  30 days

• Graft Versus Host Disease

  100 days

Study Arms (1)

Haploidentical Transplant

EXPERIMENTAL

All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.

Drug: MLN9708

Interventions

MLN9708 DRUG

MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.

Haploidentical Transplant

Eligibility Criteria

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

You may qualify if:

• Availability of a 3/6 - 5/6 matched (HLA-A, B, DR) related donor
• Donor must have negative HLA cross-match in the host vs. graft direction.
• Donor must be willing to donate mobilized peripheral blood stem cells
• Age ≥ 18 years
• Karnofsky status ≥ 70%
• One of the following high-risk malignancies:
• Chronic Myelogenous Leukemia (chronic phase, resistant and/or intolerant to tyrosine kinase inhibitors (OR) accelerated phase (OR) blast crisis in 2nd chronic phase following induction chemotherapy)
• Acute Myelogenous Leukemia (2nd or subsequent complete remission \[CR\] (OR) Primary induction chemotherapy failure, but subsequently entered into a CR(OR) 1st CR with poor risk cytogenetics or molecular markers; or arising from preceding hematological disease)
• Myelodysplastic Syndrome (treatment-related, monosomy 7 or complex cytogenetics, IPSS score of 1.5 or greater, Chronic myelomonocytic leukemia \[CMML\])
• Acute lymphocytic leukemia/lymphoblastic lymphoma (2nd or subsequent CR (OR) Primary induction chemotherapy failure, but subsequently entered into a CR (OR) 1st CR with poor risk cytogenetics)
• Chronic Lymphocytic Leukemia / Prolymphocytic Leukemia (Duration of remission \<12 months after receiving chemotherapy with a nucleoside analog (OR) High risk features (i.e. 17p deletion), (OR) Second or subsequent relapse)
• Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse) (Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation (AND) Chemoresponsive to most recent salvage therapy
• Multiple Myeloma (Presence of a poor risk cytogenetic abnormality \[i.e. 17p, t(4;14)\], Relapse post autologous transplant)

You may not qualify if:

• Poor cardiac function: left ventricular ejection fraction \<40%
• Poor pulmonary function: FEV1, FVC, or DLCO \<50% predicted
• Poor liver function: bilirubin \>2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT \> 3X ULN
• Poor renal function: Creatinine \>2.0 mg/dl or creatinine clearance (calculated creatinine clearance is permitted) \< 40 mL/min
• Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
• Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
• Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
• Systemic treatment, within 14 days before the first dose of MLN9708, with strong strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
• Patient has \>/= Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21days of the start of this trial and throughout the duration of this trial.
• Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

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• Solomon SR, Solh M, Zhang X, Brown S, Jackson KC, Holland HK, Morris LE, Bashey A. Prospective phase 2 trial of ixazomib after nonmyeloablative haploidentical peripheral blood stem cell transplant. Blood Adv. 2020 Aug 11;4(15):3669-3676. doi: 10.1182/bloodadvances.2020001958.

  PMID: 32777064 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Hematologic Neoplasms

Interventions

ixazomib

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Neoplasms by Site

Results Point of Contact

• Title: Scott R. Solomon, MD
• Organization: Northside Hospital

ssolomon@bmtga.com

404-255-1930

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: July 15, 2014
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-09

Locations

US (1)