Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Phase 1

Completed

• Conditions: Multiple Myeloma; Leukemia; Myelodysplastic Syndrome; Lymphoma

• Registration Number: NCT00809276
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Detailed Description

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2014-12-19
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-13
• Results First Posted: 2015-01-19
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patients ages between 0 to and 65 years of age.

• Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.

• Acute lymphocytic leukemia (ALL) in CR1 with high risk features

• Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

  i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

• Acute Leukemias in 2nd or greater remission

• Refractory or Relapsed AML

• AML transformed from MDS

• Myelodysplastic syndrome (MDS) beyond refractory anemia

• Chronic myeloid leukemia (CML)

• Chronic myelomonocytic leukemia

• Philadelphia-negative myeloproliferative disorder

• Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma

• Multiple Myeloma-Stage III

Exclusion Criteria

• Prior autologous or allogeneic stem cell transplant.
• Performance status greater than 2
• Active infection.
• Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
• Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
• Inadequate Serum creatinine clearance <60
• InadequatebHepatic function
• Positive serology for HIV-1, 2 or HTLV-1, 2.
• Pregnancy. Female patient must have negative pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD	1 year	Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.

Trial Locations

Locations (3)

Marcos deLima, MD; 🇺🇸 Houston, Texas, United States

Paul V. O'Donnell, M.D., Ph.D.; 🇺🇸 Seattle, Washington, United States

The Sydney Kimmel Comprehensive Cancer center; 🇺🇸 Baltimore, Maryland, United States