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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

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ClinicalTrials.gov Identifier: NCT01385072
Recruitment Status : Unknown
Verified June 2011 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : June 29, 2011
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Relapsed and Refractory Acute Leukemia Biological: Double matched sibling transplantation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Double matched sibling transplantation

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.

 Biological: Double matched sibling transplantation

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.


Outcome Measures
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Primary Outcome Measures :
  1. Acute graft versus host disease rate,severity and response to treatment [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. relapse rate [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385072


Contacts
Contact: Moshe Yeshurun, MD 972-9378127 moshey@clalit.org.il
Contact: Ron Ram, MD 972-9378116 RonRa@clalit.org.il

Locations
Israel
Davidoff Cancer Center, Beilin hospital, Rabin medical center Recruiting
Petach Tikva, Israel
Contact: Moshe Yeshurun, MD    972-3-9378127    moshey@clalit.org.il   
Contact: Ron Ram, MD    972-3-9378116    RonRa@clalit.org.il   
Principal Investigator: Moshe Yeshurun, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Yeshurun, MD Davidoff cancer center, Beilinson hospital, Rabin Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01385072     History of Changes
Other Study ID Numbers: 6188
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: June 2011

Keywords provided by Rabin Medical Center:
acute leukemia
relapse
induction failure
allogeneic transplantation
graft versus leukemia effect

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
 Neoplasms
Disease Attributes
Pathologic Processes