CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
anti-thymocyte globulin +8 morebiological
Likely dose
anti-thymocyte globulin 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00448201
NCT00448201Phase 2Completed
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Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment With a More Intensive Therapeutic Regimen

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Mar 16, 2007·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, sargramostim, and 7 other interventions for Chronic Myeloproliferative Disorders and 4 related conditions. Completed, enrolled 71 participants across 1 site.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Immunosuppressive therapy may improve bone marrow function and may be an effective treatment for hematologic cancer or other disease. PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and fludarabine with or without antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer or other disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2007
Enrollment StartJan 7, 2011
Primary CompletionJan 11, 2011
Study CompletionMay 23, 2012
TodayJul 2, 2026
Enrollment to primary: 4 daysPosted 19.3 years ago

Interventions

anti-thymocyte globulinbiological

0.5 mg/kg on day -3, 2.5 mg/kg on day -2 (groups 2, 3 and 4) and 3 mg/kg on day -1 (group 4 only)

sargramostimbiological

GM-CSF 500 ug everyday (QD) subcutaneously will be given to recipients who remain with an Absolute neutrophil count (ANC) \< 1000/microliter (uL) past day 20

therapeutic allogeneic lymphocytesbiological

A minimum total cluster of differentiation 34 (CD34)+ cell dose of 3 x 10\^6 cells/kg and a maximum 8 x 10\^6 cells/kg will be infused on day 0

busulfandrug

6.4 mg/kg by continuous IV infusion over 48 hours on Days -6 and -5

fludarabine phosphatedrug

fludarabine 30 mg/m\^2/day x 5 days IV piggyback (IVPB) over 30 minutes on Days -7 through -3

methotrexatedrug

Methotrexate 5 mg/m\^2 per day on days +1, +3 and +6

tacrolimusdrug

Suggested starting dose is 0.03 mg/kg po bid starting on Day -1

nonmyeloablative allogeneic hematopoietic stem cell transplantationprocedure

Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0

peripheral blood stem cell transplantationprocedure

Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0