Abbreviated Mycophenolate Mofetil and Sargramostim after Stem Cell Transplant in Treating Patients with High Risk or Recurrent Hematological Malignancies

Status: administratively complete

This randomized phase II trial studies how well a shortened course of treatment with mycophenolate mofetil after stem cell transplant works when given with sargramostim in treating patients with a cancer that affects the blood or bone marrow (hematological malignancy), and is at high risk for returning or came back after previous treatment (recurrent). Graft versus host disease (GVHD) is a condition that may occur after transplant, in which the stem cells that are transplanted from a donor (the "graft") attack the normal cells of the patient (the “host”). Mycophenolate mofetil is used to help prevent GVHD after transplants. Giving mycophenolate mofetil for a shorter period of time may help the transplanted cells engraft with the patient's body more quickly, which may help the patient recover after the transplant. After transplants, colony-stimulating factors, such as filgrastim, are also given to help keep the bone marrow working to fight infections until it can recover from the transplant. Sargramostim may be a more effective treatment for supporting the bone marrow function than standard treatment with filgrastim. It is not yet known whether giving abbreviated treatment with mycophenolate mofetil and sargramostim is more effective than longer treatment given with filgrastim in treating patients with high risk or recurrent hematological malignancies after transplant.

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 (MCC)-Virginia Commonwealth University Health System (VCUHS) Bone Marrow Transplant (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 should 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 human immunodeficiency virus (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

PRIMARY OBJECTIVES:

I. To determine the difference in the relapse-free/donor lymphocyte infusion (DLI)-free survival rate between patients randomized to mycophenolate mofetil (MMF)-30 days (30) (control cohort) and MMF-15 days (15). (investigational cohort)

SECONDARY OBJECTIVES:

I. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) day 60 donor-derived (dd) cluster of differentiation (CD)3.

II. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) overall survival (OS).

III. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of acute GVHD.

IV.To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of chronic GVHD.

V. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of opportunistic infection.

VI. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of graft loss.

VII. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of engraftment syndrome.

VIII. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) rate of achieving donor chimerism.

IX. To determine the difference between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) T-cell recovery kinetics following stem cell transplant (SCT)

TERTIARY OBJECTIVES:

I. To evaluate dynamic exposure to immunosuppressive therapies.

II. To determine human leukocyte antigen (HLA)-specific alloreactivity potential between HLA-identical transplant recipients.

III. To determine T-cell receptor beta and alpha repertoire restoration kinetics following SCT.

IV. To explore the association and relationship between T-cell recovery kinetics, dynamic exposure to immunosuppressive therapies, HLA-specific alloreactivity potential between HLA-identical transplant recipients, and T-cell receptor beta and alpha repertoire restoration kinetics.

V. To determine the difference in survival rate between patients with multiple myeloma in either study cohort (MMF-15 or MMF-30) and historical control patients with multiple myeloma who have relapsed but have never received an allogeneic transplant.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (MMF-15): Patients receive mycophenolate mofetil orally (PO) or intravenously (IV) twice daily (BID) on days 0-15 and sargramostim subcutaneously (SC) from post-transplant day 4 until neutrophil engraftment.

ARM II (MMF-30): Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and sargramostim SC from post-transplant day 4 until neutrophil engraftment.

After completion of study treatment, patients are followed up at 28, 42, 56, 70, 84, 180, 365, and 730 days and then annually for 3 years thereafter.

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Abbreviated Mycophenolate Mofetil and Sargramostim after Stem Cell Transplant in Treating Patients with High Risk or Recurrent Hematological Malignancies

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