Clinical Trial: Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Brief Summary:

Objectives:

A. Primary objective:

1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL).

B. Secondary objective:

  1. To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients.
  2. To prospectively evaluate gene hypermethylation status in this group of patients.
  3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.

Detailed Summary:

Induction:

During Induction, you will receive augmented Berlin-Frankfurt-Munster chemotherapy, which is made up of a combination of Cerubidine®, Daunorubicin Hydrochloride (daunorubicin), Oncovin® (vincristine), prednisone, dexamethasone, Oncaspar® (PEG Asparaginase), and MTX amethopterin (methotrexate). All of these drugs are designed to interfere with the multiplication of cancer cells to cause them to die and to keep the cancer from coming back.

If you are found to be eligible to take part in this study, on Day 1 or during the spinal tap procedure, you will be given cytarabine as an injection in your spinal fluid. Within 3 days, you will begin the Induction course, which will last for 4 weeks.

Daunorubicin and vincristine will be given through a needle in your vein on Days 1, 8,15, and 22. During the first week of therapy, you will be given 1 infusion of PEG Asparaginase by vein. You will take prednisone by mouth on Days 1-28. Methotrexate will be injected into your spinal fluid on Weeks 2 and 5 during your spinal tap. Cerebrospinal fluid (CSF) studies will be sent with each spinal tap to test the fluid for leukemia. If there is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses once a week until there is no disease present. You will continue to receive methotrexate in spinal taps every other week for 8 doses, then monthly for 6 doses.

Blood (about 3 teaspoons) will be drawn multiple times during the study for routine tests. You will have a bone marrow aspirate or biopsy on Days 15 and 29 and then as needed to confirm remission.

If you have less than 5% immature cells in the bone marrow, 1 week after I
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 3-Year Event-Free Survival (EFS) Rate [ Time Frame: 3 Years ]

Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.


Original Primary Outcome: To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). [ Time Frame: October 2010 ]

Current Secondary Outcome: Efficacy Monitoring by Patient Response [ Time Frame: 3 Years ]

Patient Response categorized as Response With Toxicity, Response Without Toxicity, No Response With Toxicity, No Response No Toxicity.


Original Secondary Outcome:

  • To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients. [ Time Frame: October 2010 ]
  • To prospectively evaluate gene hypermethylation status in this group of patients. [ Time Frame: October 2010 ]
  • To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients. [ Time Frame: October 2010 ]


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: March 19, 2009
Date Started: September 2006
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016