Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger

NCT00290498 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2005-0054NCI-2012-01355
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell lymphoma. At this point, all participants will now be assigned to the R-HCVAD arm of the study. Researchers will study the safety and effectiveness of this drug combination.

Conditions

Lymphoma

Keywords

Non-Hodgkin's Lymphoma; B-Cell Non-Hodgkin's Lymphoma; Lymphoma; Cyclophosphamide; Cytarabine; Doxorubicin; Hyper-CVAD; Methotrexate; Prednisone; Rituximab; Vincristine; R-CHOP; R-HCVAD; Dexamethasone; Decadron; Leucovorin; Ara-C; Cytosar; Cytoxan; DepoCyt; Cytosine arabinosine hydrochloride; AD; Hydroxydaunomycin hydrochloride; Neosar

Outcome Measures

Primary Outcomes (1)

• Response Rate R-HCVAD vs. R-CHOP

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  3 years

Secondary Outcomes (1)

• Progression Free Survival (Rate)

  3 years post-therapy

Study Arms (2)

Arm A

EXPERIMENTAL

R-HCVAD + R-MTX/Ara-C ((Rituximab-HCVAD (rituximab, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) alternating with Rituximab-Methotrexate-Cytarabine))

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Methotrexate

Arm B

ACTIVE COMPARATOR

R-CHOP ((Rituximab-CHOP (Rituximab, cyclophosphamide, vincristine, and prednisone)) No longer recruiting for this study arm.

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Prednisone

Interventions

Rituximab DRUG

Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles.

Also known as: Rituxan

Arm A; Arm B

Cyclophosphamide DRUG

Arm A: Cyclophosphamide 300 mg/m\^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles. Arm B: Cyclophosphamide 750 mg/m² by vein day 1

Also known as: Cytoxan, Neosar

Arm A; Arm B

Doxorubicin DRUG

Arm A: Doxorubicin 50 mg/m\^2/day by vein over 15 minutes (12 hours after last dose of cyclophosphamide) on Day 5, Cycle 1 and alternating cycles.

Also known as: AD, Hydroxydaunomycin hydrochloride

Arm A

Vincristine DRUG

Arm A: Vincristine 1.4 mg/m\^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12, Cycle 1 and alternating cycles. Arm B: Vincristine 1.4 mg/m\^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12 of each cycle.

Arm A

Dexamethasone DRUG

Arm A: Dexamethasone 40 mg by vein or by mouth daily x 4 on Days 2-5 and on days 12-15 of cycle 1 and alternating cycles.

Also known as: Decadron

Arm A

Methotrexate DRUG

Arm A: Methotrexate after finishing Rituximab, 200 mg/m2 by vein over 2 hours, then 800 mg/m2 by vein over 22 hours day 1 cycle 2.

Arm A

Cytarabine DRUG

Arm B: Cytarabine 3 g/m\^2 by vein over 2 hours every 12 hours X 4 doses on days 3 \& 4, cycle 2 and alternating cycles.

Also known as: Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride

Arm B

Prednisone DRUG

Arm B: Prednisone 100 mg by mouth (as a pill, capsule, or tablet) once a day on Days 1-5, each cycle.

Arm B

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed diagnosis of previously untreated large B-cell Non Hodgkin's, Large Cell Lymphoma and B-Cell with high grade features. Other aggressive lymphomas such as Primary Mediastinal large B-cell Lymphomas will be also allowed to be included.
• Patients with performance status of 0-2 (Zubrod Scale).
• Serum bilirubin \<1.5 mg/dl and serum creatinine \< 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (ANC) \>1000/mm\^3 and platelets \>100,000/mm\^3 unless due to lymphoma.
• Cardiac ejection fraction 50% or greater.
• Ages 16 - 60 years (due to the fact that CHOP-R is not studied enough in younger patients and is not considered standard of care).
• Patients must be willing to receive transfusions of blood products.
• Age adjusted International Prognostic Index Score of 2 or more
• Previous steroids are allowed (if used to relieve some symptoms such as SVC, etc).

You may not qualify if:

• Pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
• Positive HIV serology because of poor tolerance to this intense chemotherapy regimen
• Burkitt's lymphomas, and Mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade III.
• Any clinical or cytological diagnosis of central nervous system (CNS) involvement
• Any co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator.
• Concurrent or previous malignancy whose prognosis is poor (\< 90% probability of survival at 5 years)
• Active Hepatitis B or C. Chronic carriers for Hepatitis B will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone; Calcium Dobesilate; Methotrexate; Cytarabine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols

Results Point of Contact

• Title: Dr. Luis E. Fayad / Lymphoma/Myeloma
• Organization: U.T. MD Anderson Cancer Center

lefayad@mdanderson.org

7137922860

Study Officials

• Luis E. Fayad, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: August 1, 2005
• Primary Completion: August 11, 2017
• Study Completion: August 11, 2017
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Locations

US (1)