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

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.

Conditions

• Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

Interventions

DRUG

Daunorubicin

Starting Dose 25 mg/m\^2 by vein weekly

DRUG

Vincristine

Starting Dose 2 mg by vein weekly

DRUG

PEG-asparaginase

Starting Dose 2000 International units/m2 by vein in week 1

DRUG

Intrathecal Methotrexate

Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid

DRUG

Cyclophosphamide

Starting Dose 1g/m2 by vein in weeks 1 and 5

DRUG

Cytarabine

75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months

DRUG

Mercaptopurine

Starting Dose 60 mg/m2 by mouth on days 1-14 of each month

DRUG

Methotrexate

Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3

DRUG

Doxorubicin

25 mg/m2 by vein in weeks 1, 2 and 3

DRUG

Thioguanine

60 mg/m2 by mouth daily for two weeks

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Michael E. Rytting, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-12

Primary Completion

2018-07-26

Completion

2018-07-26

FDA Drug

Yes

Countries

• United States

Study Locations