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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01500161
• Date of registration: 18/11/2011
• Prospective Registration: No
• Primary sponsor: Texas Oncology Cancer Center
• Public title: Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
• Scientific title: A Phase II Study Of Pooled Unrelated Donor Umbilical Cord Blood (UCB) Transplant For Patients With Hematologic Malignancies Needing Allogeneic Stem Cell Transplant But Do Not Have A Related HLA-Matched Donor
• Date of first enrolment: November 2011
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01500161
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Seah Lim, MD
• Affiliation: Texas Oncology - Amarillo,TX

Key inclusion & exclusion criteria

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.

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Lymphocytic Leukemia

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Non-Hodgkins Lymphoma

Acute Myelogenous Leukemia

Chronic Myelogenous Leukemia

Aplastic Anemia

Hodgkins Disease

Multiple Myeloma

Intervention(s)

Drug: Carmustine

Drug: Melphalan

Drug: Clofarabine

Drug: Cytarabine

Drug: Fludarabine

Drug: Busulfan

Drug: Etoposide

Primary Outcome(s)

evaluate the multi-lineage hematopoietic chimerism for unrelated UCB grafts pooled from two to three cord blood units [Time Frame: Will be tested after granulocyte engraftment - which will happen at an average of 28 days post-transpant]

Secondary Outcome(s)

The Infection rate seen in the participants who received a pooled UCB transplant [Time Frame: 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.]

evaluate the antitumor responses of pooled UCB transplant [Time Frame: 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]

Number of participants that develop Graft Versus Host Disease after pooled UCB transplant [Time Frame: 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.]

Secondary ID(s)

1127920

Source(s) of Monetary Support

Please refer to primary and secondary sponsors