Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match

Phase 2

Terminated

• Conditions: Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Aplastic Anemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Multiple Myeloma; Hodgkins Disease; Non-Hodgkins Lymphoma
• Interventions: Drug: Busulfan; Drug: Clofarabine; Drug: Fludarabine; Drug: Melphalan; Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine

• Registration Number: NCT01500161
• Lead Sponsor: Texas Oncology Cancer Center

Brief Summary

The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.

Detailed Description

Hematopoietic stem cell (HSC) transplantation, using human HLA-matched sibling or unrelated bone marrow or peripheral blood stem cell donor, has been used successfully to treat patients with high-risk or relapsed hematologic malignancies. However, use of this therapy has been limited by availability of fully HLA-matched donors, despite the increasing size of...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-28
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients < 65 years with hematologic malignancies needing stem cell transplant but do not have HLA-matched sibling donor. Patients with the following diagnosis will be included:

  • AML in first or subsequent complete or partial remissions
  • ALL in first or subsequent complete or partial remissions
  • CLL in second remission or more advanced disease
  • CML who has failed tyrosine kinase inhibitors
  • Hodgkin's disease who relapse after autologous transplant
  • Non-Hodgkin's lymphoma who relapse after autologous transplant or NK-cell lymphoma in CR1
  • Aplastic anemia patients
  • Multiple myeloma in second remission or moer advanced disease, including those who have failed an autologous transplant
  • Myelodysplastic syndrome in first or subsequent complete or partial remission

• Patients must have 6/6, 5/6 or 4/6 molecular matches from unrelated UCB donors. Matching will be done for A, B, and DR. Matching at DR will be confirmed by molecular typing.

• Patients must be documented to be HIV negative. Screening must have been performed within previous 6 months.

• Patients must be able to give written consent.

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Exclusion Criteria

• Patient is excluded if all of the Inclusion criteria above isn't met.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Busulfan	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Clofarabine	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Fludarabine	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Carmustine	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Melphalan	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Etoposide	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
Single Arm	Cytarabine	The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.

Primary Outcome Measures

Name	Time	Method
evaluate the multi-lineage hematopoietic chimerism for unrelated UCB grafts pooled from two to three cord blood units	Will be tested after granulocyte engraftment - which will happen at an average of 28 days post-transpant	Blood will be obtained for DNA preparation for VNTR chimerism study post transplant after time of engraftment, which will happen at an average of 28 days post-trasplant.

Secondary Outcome Measures

Name	Time	Method
evaluate the antitumor responses of pooled UCB transplant	Disease staged at baseline, then disease status re-assessed at 6 weeks, 3 months, 6 months, 9 months, 12 months and after that every 6 months post-transplant	Baseline - All patients will have a detailed history and physical examination, CBC, complete biochemical profile and full staging procedure appropriate for the underlying disease.; ...
Number of participants that develop Graft Versus Host Disease after pooled UCB transplant	Patients will be assessed weekly during first 28 days then re-assessed at 6 weeks, 3 months, 6 months, 9 months, 12 months and after that every 6 months post-transplant.	Baseline - All patients will have a detailed history and physical examination, CBC, complete biochemical profile.; ...
The Infection rate seen in the participants who received a pooled UCB transplant	Patients will be assessed weekly during first 28 days then re-assessed at 6 weeks, 3 months, 6 months, 9 months, 12 months and after that every 6 months post-transplant.	Baseline - All patients will have a detailed history and physical examination, CBC, complete biochemical profile.; ...

Trial Locations

Locations (1)

Texas Oncology; 🇺🇸 Amarillo, Texas, United States