Trial of a Single ProHema-CB Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies
Status: Recruiting
Phase: Phase 2
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01627314
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-321
This study is an open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative conditioning for subjects age 15-55 years with hematologic malignancies. A maximum of 45 eligible subjects will be enrolled and treated in the trial at approximately 6-10 centers within the U.S.
Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Children's Hospital Boston
Overall PI:
Corey Cutler, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Karen Ballen, MD,
Massachusetts General Hospital
Christine Duncan, MD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Kimberly Phillips,
kimberly_phillips@dfci.harvard.edu
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Eligibility Criteria
Inclusion Criteria:
1. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation
is deemed clinically appropriate. Eligible diseases and stages include:
- Acute lymphoblastic leukemia (including T lymphoblastic leukemia) in complete
remission.
- Remission is defined as < 5% blasts with no morphological characteristics of
acute leukemia in a bone marrow with > 20% cellularity.
- Acute myelogenous leukemia in high risk first CR or second or subsequent CR.
- High risk first CR is defined by but is not limited to at least one of the
following factors: greater than 1 cycle of induction chemotherapy to achieve CR,
prior myelodysplastic syndrome (MDS), presence of Flt3 abnormalities, FAB M6 or
M7 subtypes of leukemia, or adverse cytogenetics.
- Remission is defined as < 5% blasts with no morphological characteristics of
acute leukemia (e.g. Auer Rods) in a bone marrow with > 20% cellularity.
- Biphenotypic/Undifferentiated leukemia in first or subsequent CR (same
definition of CR as for ALL/AML).
- Non-Hodgkin's lymphoma (T-cell, large cell or mantle cell) or Hodgkin's lymphoma
in second or subsequent complete remission (CR) or in partial remission (PR)
with documented chemosensitivity. In addition, marginal zone lymphoma or
follicular lymphoma that has progressed after ≥ 2 therapies (excluding
single-agent rituximab). No history of prior myeloablative procedure.
2. Lack of suitable 5-6/6 HLA-matched related or (if institutional guidelines dictate)
suitable 8/8 HLA-A, B, C, DRß1 matched unrelated donor; or unrelated donor not
available within appropriate timeframe.
3. Age 15-55 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Signed IRB approved Informed Consent Form (ICF).
Exclusion Criteria:
1. History of prior allogeneic transplantation
2. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
dysfunction (Ejection fraction < 40%) as measured by gated radionuclide
ventriculogram or echocardiogram; active angina pectoris, or uncontrolled
hypertension; history of myocardial infarction with depressed ejection fraction.
3. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for
hemoglobin.
4. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40
mL/min.
5. Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's
syndrome or ongoing hemolytic anemia), SGOT or SGPT > 5 x upper limit of normal.
6. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation.
7. HIV antibody.
8. Uncontrolled infection.
9. Pregnancy or breast feeding mother.
10. Inability to comply with the requirements for care after allogeneic stem cell
transplantation.