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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT00290628
Date of registration:	09/02/2006
Prospective Registration:	No
Primary sponsor:	Masonic Cancer Center, University of Minnesota
Public title:	Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
Scientific title:	Transplantation of Umbilical Cord Blood From Related and Unrelated Donors
Date of first enrolment:	October 1999
Target sample size:	43
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT00290628
Study type:	Interventional
Study design:	Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	John E. Wagner, MD
Address:
Telephone:
Email:
Affiliation:	Masonic Cancer Center, University of Minnesota

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Leukemia including, but not limited to, the following subtypes:

- Chronic myelogenous leukemia

- Acute myeloid leukemia (primary or secondary)

- Acute lymphoblastic leukemia

- Lymphoma

- Myelodysplastic syndrome

- Aplastic anemia

- Fanconi's anemia

- Diamond-Blackfan anemia

- Inborn errors of metabolism (e.g., Hurler syndrome, Maroteaux-Lamy syndrome,
myelodysplastic syndrome VI, metachromatic leukodystrophy, adrenoleukodystrophy,
and globoid cell leukodystrophy)

- Immune deficiency disorders

- Patients must meet the eligibility requirements outlined in currently active treatment
protocols of the University of Minnesota Bone Marrow Transplant Program

- HLA-identical or 1, 2, or 3 antigen mismatched umbilical cord blood (UCB) donor with
at least one DRB1 match available

- Unrelated or related donor

- UCB specimen must contain = 2.0 x 10^7 nucleated cells/kg patient body weight

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- No active infection

- No history of HIV infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- Not specified

Age minimum: N/A
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Myeloproliferative Disorders

Multiple Myeloma and Plasma Cell Neoplasm

Leukemia

Diamond-blackfan Anemia

Fanconi Anemia

Graft Versus Host Disease

Myelodysplastic Syndromes

Lymphoma

Myelodysplastic/Myeloproliferative Diseases

Intervention(s)

Drug: filgrastim

Drug: cyclosporine

Drug: mycophenolate mofetil

Drug: methylprednisolone

Drug: busulfan

Procedure: umbilical cord blood transplantation

Drug: anti-thymocyte globulin

Drug: cyclophosphamide

Procedure: radiation therapy

Drug: melphalan

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

UMN-MT1999-28

2000LS017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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