T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia

  • STATUS
    Recruiting
  • End date
    May 9, 2022
  • participants needed
    15
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 9 June 2021

Summary

The main purpose of this study is to learn if a new combination of chemotherapy, in combination with low-dose radiation, will be safe for the patient, and at the same time provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy and radiation described in the study is considered 'low intensity.' Although the chemotherapy agents used in this study and for transplant are FDA approved, the chemotherapy treatment and conditioning regimens or combinations listed in this consent are not yet FDA approved.

The CliniMACS device is FDA approved for one type of T cell depletion (positive selection of the stem cells) but not approved yet for other type of T cell depletion, which is being studied on this protocol. This pilot study, along with other studies will serve as the basis for FDA approval, if outcomes are favorable.

Details
Condition Myeloid Diseases
Treatment cyclophosphamide, allogeneic hematopoietic stem cell transplantation, Fludarabine, Total body irradiation, Rituxan, Antithymocyte globulin (Rabbit)
Clinical Study IdentifierNCT03531736
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with one of the high risk myeloid diseases as outlined below. Patients must have 5% blasts on the last BM evaluation prior to starting the conditioning regimen. Diseases included on this protocol include
Acute Myeloid Leukemia (AML) in CR1 with intermediate or high risk features as defined below
Cytogenetic abnormalities which are not considered "good risk" cytogenetic
features (i.e t(8:21), t(15:17), inv 16 without c-kit mutations
And/or
Therapy related AML with history of antineoplastic therapy (radiation and/or chemotherapy) And/or
Normal karyotype with mutations of FLT3, RUNX1, TP53 mutation, ASXL1 or any others that are considered to be high risk 2. AML in 2nd remission 3. Myelodysplastic syndrome, myeloproliferative neoplasms, or MDS/MPN overlap syndrome with
International prognostic scoring system risk score INT-2 or high risk at the
time of transplant evaluation
And/or
Any risk category if life-threatening cytopenia exists And/or
Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype. 4. Chronic myelomonocytic leukemia (CMML) 5. Chronic myeloid leukemia (CML) with the following features
Patients who have failed or are intolerant to BCR-ABL tyrosine kinase
inhibitors
And/or
CML with BCR-ABL mutation consistent with poor response to tyrosine kinase
inhibition (e.g T351l mutation)
\. Patients with severe aplastic anemia
Chronic lymphocytic leukemia (CLL) with high risk disease as defined by the EBMT consensus criteria
Non-Hodgkin lymphoma meeting both of the following criteria
Responding to therapy prior to enrollment
Relapse after prior autologous bone marrow transplant or are ineligible for autologous bone marrow transplant
Multiple Myeloma with disease in the following categories
Patients with relapsed multiple myeloma following autologous stem cell transplantation who have achieved at least partial response following additional chemotherapy
Patients with high risk cytogenetics at diagnosis must have achieved at least a partial response following autologous stem cell transplantation. Patients must have complex karyotype, del17p, t4;14, and/or t14;16 by FISH and/or del13 by karyotyping
Each patient must be willing to participate as a research participant and must sign an informed consent form
Organ Function and Performance Status Criteria
Patients be 18 years old
Patients must have a Karnofsky (adult) or Performance Status 70%
Patients must have adequate organ function measured by
Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be 40% and must improve with exercise
Hepatic: < 5x ULN ALT and < 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia
Renal: CrCl >30ml/min (measured or calculated/estimated)
Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)

Exclusion Criteria

Prior allogenic hematopoietic stem cell transplantation
Prior radiation therapy with 400cGY or more of TBI
BM with increased fibrosis (Reticulin stain > 1/3)
Active and uncontrolled infection at time of transplantation
HIV infection
Seropositivity for HTLV-1
Inadequate performance status/ organ function
Pregnancy or breast feeding
Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
Donor Inclusion and Exclusion Criteria
Must be a 10/10 HLA genotypically match related or unrelated donor at all A, B, C, DRB1, and DQB1 loci, as tested by DNA analysis
Able to provide informed consent for the donation process per institutional standards
Meet standard criteria for donor collection as defined by the National Marrow Donor Program Guidelines
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