Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

NCT00559104 | Completed Phase 2 Results DMC

• 4 other identifiers: 97133P30CA033572CHNMC-97133CDR0000573523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV mantle cell lymphoma; stage III mantle cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (2)

• Progression

  Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first. Below is reported Progression-free Survival: event is relapse or progression, or death.

  Assessed at date of progression post-transplant

• Mortality

  Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.

  Assessed at date of death post-transplant

Secondary Outcomes (1)

• Short-term and Long-term Treatment-related Toxicities

  Any time after transplant

Study Arms (2)

Irradiation in conditioning

ACTIVE COMPARATOR

total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation

Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation; Drug: G-CSF

Carmustine in conditioning

ACTIVE COMPARATOR

Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation

Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Drug: G-CSF

Interventions

carmustine DRUG

Unique to the Carmustine in Conditioning arm

Also known as: BCNU

Carmustine in conditioning

cyclophosphamide DRUG

Used in Both Arms

Also known as: Cytoxan, CTX

Carmustine in conditioning; Irradiation in conditioning

etoposide DRUG

Used in Both Arms

Also known as: VP-16

Carmustine in conditioning; Irradiation in conditioning

autologous hematopoietic stem cell transplantation PROCEDURE

Both arms are given autologous stem cell transplantation

Carmustine in conditioning; Irradiation in conditioning

peripheral blood stem cell transplantation PROCEDURE

Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).

Carmustine in conditioning; Irradiation in conditioning

total-body irradiation RADIATION

Unique to the Radiation in Conditioning Arm

Irradiation in conditioning

G-CSF DRUG

G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.

Also known as: Granulocyte-colony stimulating factor

Carmustine in conditioning; Irradiation in conditioning

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• DISEASE CHARACTERISTICS:
• Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma \[SNCCL\] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL)
• SNCCL patients with all of the following factors at presentation of disease:
• Lactate dehydrogenase (LDH) \> 500 IU/L
• Unresectable bulky mass \> 10 cm
• Stage IV disease with bone marrow involvement
• MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis
• Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI
• Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4
• Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass \> 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan
• Must have attained a complete response or partial response to first-line standard conventional chemotherapy
• ECOG PS 0-1 OR Karnofsky PS 80-100%
• Serum creatinine \< 1.5 mg/dL OR creatinine clearance \> 60 mL/min
• FEV\_1 \> 65% of predicted measurement or DLCO ≥ 45% of predicted measurement
• Cardiac ejection fraction \> 50% by echocardiogram

You may not qualify if:

• Evidence of lymphoma or \< 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy
• Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
• Positive HIV antibody
• Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin
• Hepatitis B surface antigen positivity
• Prior bone marrow transplantation
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior bone marrow transplantation

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Good Samaritan Regional Medical Center

Phoenix, Arizona, 85006, United States

Location

City of Hope National Medical Center--Main Campus

Duarte, California, 91010-3000, United States

Location

Related Publications (1)

• Nademanee A, Molina A, Dagis A, Snyder DS, O'Donnell MR, Parker P, Stein A, Smith E, Planas I, Kashyap A, Spielberger R, Fung H, Krishnan A, Bhatia R, Wong KK, Somlo G, Margolin K, Chow W, Sniecinski I, Vora N, Slovak M, Niland JC, Forman SJ. Autologous stem-cell transplantation for poor-risk and relapsed intermediate- and high-grade non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Jun;1(1):46-54. doi: 10.3816/clm.2000.n.004.

  PMID: 11707813 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma

Interventions

Carmustine; Cyclophosphamide; Etoposide; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Radiotherapy; Investigative Techniques; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Auayporn Nademanee
• Organization: City of Hope National Medical Center

anademanee@coh.org

626-256-4673

Study Officials

• Auayporn P. Nademanee, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: October 1, 1998
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 11, 2015
• Results First Posted: August 11, 2015

Record last verified: 2015-07

Locations

US (2)