Allogeneic Stem Cell Transplantationin Relapsed Hematological Malignancy: Early GVHD Prophylaxis

• Status: Active, not recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients receiving the investigational regimen.This is a randomized phase II clinical trial, comparing two different dosing schedules of mycophyenolate mofetil for graft versus host disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study arms will be performed based on T cell counts at day 60.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Massey Cancer Center
• Treatments: Antilymphocyte Serum; Lenograstim; Molgramostim; Mycophenolate mofetil; Mycophenolic Acid; Sargramostim; Tacrolimus

Criteria

Inclusion Criteria

• Any of the following high risk or recurrent hematological malignancies:

• Hodgkin lymphoma (HL)

• Non-Hodgkin lymphoma (NHL)

• Chronic lymphocytic leukemia (CLL)

• Multiple myeloma (MM)

• Acute myelogenous leukemia (AML)

• Acute lymphocytic leukemia (ALL)

• Chronic myelogenous leukemia (CML)

• Myelodysplastic syndrome (MDS)

*Note: Determination that the malignancy is high risk will be made by the investigator.

• Investigator determination that the patient is an appropriate candidate for reduced intensity allogeneic SCT with the standard Massey Cancer Center-Virginia Commonwealth Health System Bone Marrow Transplant MCC-VCUHS BMT Program regimen employed in this trial

• Patients with or without previous myeloablative autologous transplant

• HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)

*Note: Unrelated donors must be matched at HLA-A, -B, -C, and -DRB1 loci. However, a single locus mismatch will be acceptable in the event a more closely matched donor is not available.

• Age ≥ 40 to < 75 years; patients 18 to 39 years of age will be eligible only if the investigator has determined that the patient has comorbidity(ies) precluding conventional allogeneic transplantation with full intensity myeloablative conditioning

• Karnofsky Performance Status of 70-100%

• Negative serology for HIV

• Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines

• Ability to understand and the willingness to sign a written informed consent document *Note: The consent form must be signed and dated prior to initiation of SCT preparative treatments.

Exclusion Criteria

• Previous therapeutic radiation therapy (RT) that exceeds critical structure tolerance doses as determined by a radiation oncologist

• Uncontrolled viral, fungal, or bacterial infection

• Active meningeal or central nervous system disease

• Previous therapy with rabbit anti-thymocyte globulin (ATG); previous treatment with equine ATG is allowed if more than 3 months ago

*Note: Previous myeloablative autologous transplant is permitted but not required.

• Pregnancy or breastfeeding

• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements