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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

Primary Purpose

Relapsed and Refractory Acute Leukemia

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Double matched sibling transplantation
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed and Refractory Acute Leukemia focused on measuring acute leukemia, relapse, induction failure, allogeneic transplantation, graft versus leukemia effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Davidoff Cancer Center, Beilin hospital, Rabin medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Double matched sibling transplantation

Arm Description

Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient. Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

relapse rate

Full Information

First Posted
June 28, 2011
Last Updated
November 14, 2011
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01385072
Brief Title
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
Official Title
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed. Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect. The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and Refractory Acute Leukemia
Keywords
acute leukemia, relapse, induction failure, allogeneic transplantation, graft versus leukemia effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double matched sibling transplantation
Arm Type
Experimental
Arm Description
Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient. Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
Intervention Type
Biological
Intervention Name(s)
Double matched sibling transplantation
Intervention Description
Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient. Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
Primary Outcome Measure Information:
Title
Acute graft versus host disease rate,severity and response to treatment
Time Frame
100 days
Secondary Outcome Measure Information:
Title
relapse rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning. 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. Patients with 2 matched siblings and donor age > 18 years old. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation. Exclusion Criteria: Patient age < 18 years. Donor age < 18 years. Patients in remission or not fulfilling above disease criteria -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshe Yeshurun, MD
Phone
972-9378127
Email
moshey@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Ram, MD
Phone
972-9378116
Email
RonRa@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Yeshurun, MD
Organizational Affiliation
Davidoff cancer center, Beilinson hospital, Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davidoff Cancer Center, Beilin hospital, Rabin medical center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Yeshurun, MD
Phone
972-3-9378127
Email
moshey@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ron Ram, MD
Phone
972-3-9378116
Email
RonRa@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Moshe Yeshurun, MD

12. IPD Sharing Statement

Learn more about this trial

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

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