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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01036009
Other study ID # CC# 09082
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received December 17, 2009
Last updated October 26, 2014
Start date October 2009
Est. completion date July 2015

Study information

Verified date October 2014
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD. We are initiating this study of post-transplant fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving full donor chimerism in children with hematologic malignancies. If our hypothesis that full donor chimerism results in leukemia-free survival is correct, using immune modulation to achieve full donor chimerism should decrease relapse rate and thus increase survival. The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy.


Description:

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Other known NCT identifiers
  • NCT00975598

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

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Intervention

Other:
Withdrawal of immunosuppression and donor lymphocyte infusion
Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.

Locations

Country Name City State
United States University of California San Francisco California
United States All Children's Hospital St. Petersburg Florida

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco All Children’s Hospital Johns Hopkins Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Horn B, Soni S, Khan S, Petrovic A, Breslin N, Cowan M, Pelle-Day G, Cooperstein E, Baxter-Lowe LA. Feasibility study of preemptive withdrawal of immunosuppression based on chimerism testing in children undergoing myeloablative allogeneic transplantation for hematologic malignancies. Bone Marrow Transplant. 2009 Mar;43(6):469-76. doi: 10.1038/bmt.2008.339. Epub 2008 Oct 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse at 2 Years Post-transplant. Definition of relapse was >5 % blasts in bone marrow 2 years post transplant. No
Secondary 2 Years Post-transplant Survival. 2 years post transplant Yes
Secondary The Incidence of Acute Graft Versus Host Disease (aGVHD). Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea.
2 years post transplant Yes
Secondary The Incidence of Chronic GVHD (cGVHD). Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955.
The diagnosis of chronic GVHD requires the following:
1) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses.
Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores.
2 years post transplant Yes
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