Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Overview

This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.

SparkCures ID 773
Trial Phase Phase 2
Enrollment 30 Patients
Treatments
Trial Sponsors
  • Thomas Jefferson University
NCT Identifier

NCT02566304

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Patients treated on this study will have:
    1. Acute myeloid leukemia in morphologic CR not requiring treatment for their disease for 6 weeks
    2. A history of AML with < 20% residual blasts after induction therapy and persisting with <20% blasts for at least 8 weeks without reinduction.
    3. RA or RARS or isolated 5q- can proceed to transplant without any treatment
    4. RAEB-1, RCMD+/-RS, or MDS NOS with stable disease for 6 months (as documented by serial bone marrow examinations) in the absence of any therapy but growth factors or transfusion support. Patients who require treatment to "control their disease" must show chemo-responsiveness
    5. CMML or RAEB-2 must demonstrate chemo-responsiveness. Chemo-responsiveness is defined as a blast percentage decrease by at least 5 percentage points and there must be less than 20% blasts after treatment and at the time of transplant
    6. Hodgkin or Indolent Non-Hodgkin's lymphoma
    7. Myeloma with < 5% plasma cells in the marrow
    8. Myeloproliferative disorders
    9. Aplastic Anemia
    10. A hematological or oncological disease (not listed) in which allogeneic HSCT is thought to be beneficial, and the disease is chemoresponsive.
    11. Patients without clear manifestation of their disease status in terms of stage and/or responsiveness should be discussed with the PI and enrollment analysis should be documented in the study records.
  2. Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Statistical Section). The HLA matched related category includes patients with a syngeneic donor.
  3. Patients must adequate organ function:
    1. LVEF (Left ventricular end diastolic function) of >/=45%.
    2. DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥45% of predicted corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second ≥50% of predicted
    3. Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
    4. Creatinine Clearance of ≥ 60 mL/min
  4. HCT-CI/Age Score ≤ 5 points
  5. KPS≥ 90% patients older than 70 years, KPS≥ 80% patients younger than 70 years
  6. Patients must be willing to use contraception if they have childbearing potential

Exclusion Criteria:

  1. Performance status < 90% in patients 70 years old or greater, <80% in patients less than age 70 years
  2. HCT-CI/age Score >5 points
  3. HIV positive
  4. Active involvement of the central nervous system with malignancy
  5. Inability to obtain informed consent from patient or surrogate
  6. Pregnancy
  7. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
  8. Patients who have received alemtuzumab within 6 weeks of the transplant admission, or who have recently received horse or rabbit ant-thymocyte globulin and have an anti-thymocyte globulin level of > 2 ugm/ml
  9. Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Pennsylvania

Resources

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