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NCT00105001 · ClinicalTrials.gov registry record · Phase 2

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

A Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
210
Enrollment target
11
Study locations

NCT00105001: Completed Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.

NCT00105001 is a Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 210 participants, below the 467-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00105001, a Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
210 participants
Enrollment target
11
Study locations

Study Summary

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.

Primary Outcome

Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GV

Conditions Studied

Waldenstrom Macroglobulinemia Refractory Plasma Cell Myeloma Refractory Chronic Lymphocytic Leukemia Adult Acute Myeloid Leukemia in Remission Previously Treated Myelodysplastic Syndrome Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL

Interventions

  • RADIATION Total-Body Irradiation
  • DRUG Fludarabine Phosphate
  • DRUG Tacrolimus
  • PROCEDURE Peripheral Blood Stem Cell Transplantation
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (11)

Other

  • Rigshospitalet University Hospital - Copenhagen
  • Medizinische Univ Klinik Koln - Cologne
  • Universitaet Leipzig - Leipzig
  • University of Tuebingen-Germany - Tübingen

Utah

  • Huntsman Cancer Institute/University of Utah - Salt Lake City
  • LDS Hospital - Salt Lake City

Washington

  • Veterans Administration Center-Seattle - Seattle
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle

Colorado

  • Presbyterian - Saint Lukes Medical Center - Health One - Denver

Georgia

  • Emory University/Winship Cancer Institute - Atlanta

Wisconsin

  • Froedtert and the Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2004-11
Est. Completion 2015-05-08
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00105001 record still lists

NCT00105001 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 467-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (55% lower).

The record links to 10 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 5 interventions - of which Total-Body Irradiation is the first listed.

NCT00105001 lists 11 locations in 6 states (Other, Utah, Washington).

Frequently Asked Questions

What is clinical trial NCT00105001 about?

NCT00105001 is a clinical study titled "Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer". This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as f...

What is the current status of trial NCT00105001?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2004-11. Estimated completion is 2015-05-08.

What conditions does trial NCT00105001 study?

This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Refractory Plasma Cell Myeloma, Refractory Chronic Lymphocytic Leukemia, Adult Acute Myeloid Leukemia in Remission, Previously Treated Myelodysplastic Syndrome.

What interventions are being tested in trial NCT00105001?

The interventions under investigation include: Total-Body Irradiation (RADIATION), Fludarabine Phosphate (DRUG), Tacrolimus (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00105001?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00105001 being conducted?

This trial has 11 study locations across Colorado, Georgia, Utah, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Waldenstrom Macroglobulinemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00105001's enrollment target sits among peer trials

210 6th of 34 higher than 29 of 34 other Waldenstrom Macroglobulinemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Waldenstrom Macroglobulinemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00105001, the US trial registry maintained by the National Library of Medicine. NCT00105001 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.