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Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed and Refractory Acute Leukemia

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Trial Information

Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies


Inclusion Criteria:



1. Age 18 years or older

2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative
conditioning.

3. Patients with refractory or relapsed acute leukemia able to receive myeloablative
conditioning but with the following factors:

AML- 2 or more of the following: duration of CR1 < 6 months, poor cytogenetics,
circulating blasts, karnofsky < 90.

ALL- age > 40 or second and additional relapse, or 2 or more of the following: BM
blasts > 25%, age 18-39,first refractory relapse, donor CMV positive.

4. Patients with 2 matched siblings and donor age > 18 years old.

5. Patients with advanced multiple myeloma with life expectancy of less than 6 months
with standard therapy or transplantation.

6. Patients with advanced lymphoma with life expectancy of less than 6 months with
standard therapy or transplantation.

Exclusion Criteria:

1. Patient age < 18 years.

2. Donor age < 18 years.

3. Patients in remission or not fulfilling above disease criteria -

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute graft versus host disease rate,severity and response to treatment

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Moshe Yeshurun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Authority:

Israel: Ethics Commission

Study ID:

6188

NCT ID:

NCT01385072

Start Date:

August 2011

Completion Date:

April 2015

Related Keywords:

  • Relapsed and Refractory Acute Leukemia
  • acute leukemia
  • relapse
  • induction failure
  • allogeneic transplantation
  • graft versus leukemia effect
  • Leukemia
  • Acute Disease

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