Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies

NCT00208923 | Completed Phase 2 DMC

• 1 other identifier: 0709-1997
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being asked to take part in this study. This study uses a new chemotherapy regimen and matched volunteer stem cell transplant to treat patients with cancers of this kind.

Conditions

Hematologic Malignancies

Keywords

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Assess activity of preparative regimen in patients with CML, AML, RAEB, RAEB-t, CLL, NHL, HD, in all patients with refractory anemia, ringed sideroblasts, undergoing allogeneic stem cell transplantation from volunteer matched unrelated donor (VUD).

  6 months

Secondary Outcomes (1)

• Determine disease-free and overall survival.

  2 years+

Study Arms (1)

1

ACTIVE COMPARATOR

Chemotherapy-only conditioning regimen comprising busulfan (Bu), cyclophosphamide (Cy) and fludarabine (FLUDARA) followed by an allogeneic stem cell transplant.

Drug: Busulfan, Cyclophosphamide and Fludarabine

Interventions

Busulfan, Cyclophosphamide and Fludarabine DRUG

* Bulsufan 1mg/kg/dose P.O. every 6 hours for 4 days. If intravenous, busulfan dose will be 0.8 mg/kg every 6 hours for 16 doses. * Fludarabine 40 mg/m2 a day for 5 days via IV over 2 hours, dose based on weight. * Cyclophosphamide given via IV over 1 hour at dose of 60 mg/kg/day for 2 consecutive days.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible to participate in this study must have CML in the first chronic phase, AML in the first complete remission, AML in second remission, ALL or hybrid leukemia in the first complete remission, ALL in second remission, or advanced MDS. Final eligibility for this study will be determined by the health professionals conducting the trial.

You may not qualify if:

• Patients with active CNS malignant disease, or an invasive/systemic fungal infection are not eligible to participate in this study. Patients who are lactating, or who have an HLA identical or 1 antigen mismatched relative who is eligible and willing to donate bone marrow will also be excluded from the study. Final eligibility for this study will be determined by the health professionals conducting the trial.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Universtiy Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Busulfan; Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Amelia Langston, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 1998
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

US (1)