Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

PETHEMA Foundation

Status and phase

Unknown

Phase 2

Conditions

Burkitt Lymphoma (BL)

Unclassifiable Lymphoma Between DCBL and BL

Mature B-Cell Leukemia Burkitt Type

Treatments

Drug: Etoposide

Drug: Vincristine

Drug: Iphosphamid

Drug: Hydrocortisone

Drug: Prednisone

Drug: Cytarabine

Drug: Dexamethasone

Drug: Vindesine

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT05049473

BURKIMAB-14

Details and patient eligibility

About

Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.

Full description

Patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. Patients older than 55 years will receive the six blocks with attenuated chemotherapy.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years old
Patients diagnosed with de novo mature B-ALL, Burkitt lymphoma (BL). Under physician's criteria, patients with unclassified B-lymphoma with intermediate characteristics between DLBCL and BL could be included.
Candidate to intensive treatment.

Exclusion criteria

Other ALL subtype different from mature B-ALL/BL
Severe complications not due to mature B-ALL/BL (eg, sepsis, pneumonia, shock or hemorrhage) at diagnosis.
Renal failure not due to mature B-ALL /BL
Heart or liver failure
Severe lung disease
Secondary mature B-ALL/BL
Hypersensitivity to foreign proteins
Previous treatment with cytotoxic drugs
Pregnancy/breastfeeding
Severe psychiatric disease
Lack of social or familiar support

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Chemotherapy

Experimental group

Description:

Pts with biological age up to 55 y with advanced stage will receive 6 cycles of intensive treatment: blocks (A1-B1-C1-A2-B2-C2). If after A1 and B1 cycles CR is observed, the rest of the cycles will be administered with reduced doses. In pts with biological age \>55 y with advanced stage block will receive A and B with attenuated doses (A1\*-B1\*-A2\*-B2\*-A3\*-B3\*). Pts with biological age up to 55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 blocks. If CR is not reached, patients will complete the 6 treatment cycles. Pts with a biological age \>55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 attenuated blocks (A1\*-B1\*-A2\*-B2\*). If CR is not reached, patients will complete the 6 cycles of treatment.

Treatment:

Drug: Cytarabine

Drug: Iphosphamid

Drug: Rituximab

Drug: Dexamethasone

Drug: Doxorubicin

Drug: Methotrexate

Drug: Vindesine

Drug: Prednisone

Drug: Cytarabine

Drug: Hydrocortisone

Drug: Cyclophosphamide