Allogeneic Stem Cell Transplantationin Relapsed Hematological Malignancy: Early GVHD Prophylaxis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2022
• Main ID: NCT02593123
• Date of registration: 29/10/2015
• Prospective Registration: Yes
• Primary sponsor: Virginia Commonwealth University
• Public title: Allogeneic Stem Cell Transplantationin Relapsed Hematological Malignancy: Early GVHD Prophylaxis
• Scientific title: Adoptive Immunotherapy in Patients With Relapsed Hematological Malignancy: Effect of Duration and Intensity of Early GVHD Prophylaxis on Long-Term Clinical Outcomes
• Date of first enrolment: November 4, 2015
• Target sample size: 31
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02593123
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Amir A Toor, MD
• Affiliation: Massey Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma

Non Hodgkin Lymphoma

Recurrent Acute Myeloid Leukemia, Adult

Myeloma

Recurrent Non-Hodgkin Lymphoma

Acute Myelogenous Leukemia

Multiple Myeloma

Acute Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Leukemia

Myelodysplastic Syndromes

Recurrent Chronic Myelogenous Leukemia

Chronic Myelogenous Leukemia

Recurrent Chronic Lymphocytic Leukemia

Recurrent Hodgkin Lymphoma

Hodgkin's Lymphoma

Recurrent Plasma Cell Myeloma

Lymphoid Leukemia

Intervention(s)

Drug: mycophenolate mofetil

Biological: Filgrastim

Biological: Sargramostim

Primary Outcome(s)

The differences in the relapse-free/donor lymphocyte infusion(DLI)-free survival rates between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort). [Time Frame: 5 years]

Secondary Outcome(s)

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. [Time Frame: 5 years]

The differences in the rates of engraftment syndrome between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

The differences in the rates of achieving donor chimerisms between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort). [Time Frame: 5 years]

The differences in the Overall survival (OS) between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

The differences in the rates of graft loss between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

The differences in the rates of opportunistic infections between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

The differences in the rates of T-cell recovery kinetics following SCT between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort). [Time Frame: 5 years]

The differences in the rates of acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) [Time Frame: 5 years]

Secondary ID(s)

HM20005586

MCC-14-10739

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Massey Cancer Center