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LymphomaPhase 3NCT00002835

Combination Chemotherapy in Treating Patients With Lymphoma

A Phase 3 study testing Bleomycin Sulfate (BLM), Filgrastim (G-CSF) and Recombinant Interferon Alfa in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study

Who is it for?
Ages 15 to 59 years
Conditions the study is for
Lymphoma
What is being tested?
Bleomycin Sulfate (BLM), Filgrastim (G-CSF) and Recombinant Interferon Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteUnited States
Study dates
30 Oct 1995to 4 Feb 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma
  • Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :
  • Ann Arbor stage III or IV disease
  • B symptoms (fever, sweats, and weight loss greater than 10%)
  • At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray
  • Beta-2 microglobulin at least 3.0
  • Lactic dehydrogenase at least 1.1 times the upper limit of normal
  • T- and B-cell lymphomas allowed if intermediate grade or immunoblastic
  • Divergent histologies, including bone marrow involvement, allowed
  • CNS involvement allowed NOTE: A new classification scheme for adult non-Hodgkin's 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.

PATIENT CHARACTERISTICS:

Age:

  • 15 to 59

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)

Renal:

  • Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)

Cardiovascular:

  • LVEF greater than 50% by echocardiogram if over age 45
  • No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation

Pulmonary:

  • No history of chronic obstructive or restrictive lung disease
  • Pulmonary consultation required for smokers or patients with questionable lung function

Other:

  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)
  • No geographic, economic, emotional, or social condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No prior endocrine therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of early intensification vs alternating triple chemotherapy in patients with intermediate-grade or immunoblastic lymphoma with poor prognostic features.
  • Compare, in a prospective manner, the cost/benefit ratio of these regimens in these patients.
  • Determine the value of monitoring minimal residual disease detection via in vitro culture methods and polymerase chain reaction analysis of peripheral stem cell apheresis products and by longitudinal monitoring of blood and bone marrow samples in these patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to tumor score (3 or 4 vs 5 or 6).

During the first course of induction, patients receive IDSHAP comprising idarubicin (IDA) and cisplatin IV continuously on days 1-4, cytarabine (ARA-C) IV over 2 hours on day 5, and methylprednisolone (MePRDL) IV over 15 minutes on days 1-5. During the second course of induction, patients receive MBIDCOS comprising vincristine, bleomycin, and cyclophosphamide IV over 15 minutes on day 1, IDA IV continuously and MePRDL IV over 15 minutes on days 1-3, methotrexate (MTX) IV over 2 hours on day 10, and oral leucovorin calcium every 6 hours on days 11 and 12. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease after induction are randomized to 1 of 2 treatment arms.

Arm I

  • Patients receive the following 3 courses of early intensification.
  • First course: Patients receive ifosfamide (IFF) IV continuously and etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest.
  • Second course: Patients receive IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in the first course.
  • Third course: Patients receive carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity.

Arm II

  • Patients receive IDSHAP during courses 2 and 5, MBIDCOS during courses 3 and 6, and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1, 4, and 7. Each course lasts 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients with residual disease after completion of arm I or II treatment undergo radiotherapy to areas of bulk disease if feasible. Patients on both arms with meningeal involvement receive ARA-C intrathecally (IT) alternated with MTX every other day until 1 week after clearing of CNS disease and then 2 IT injections during every course of chemotherapy thereafter. Patients with divergent histology who achieve complete response after completion of arm I or II treatment receive interferon alfa 3 times a week for 1 year.

Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A maximum of 136 patients will be accrued for this study within 4 years.

Conditions
Lymphoma
Being tested
Bleomycin Sulfate (BLM), Filgrastim (G-CSF), Recombinant Interferon Alfa, Carmustine, Cisplatin (CDDP)
Keywords
stage I grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bleomycin Sulfate (BLM)Biological

    Also called Blenoxane, BLM

  • Filgrastim (G-CSF)Biological

    Also called G-CSF, Neupogen

    Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.

  • Recombinant Interferon AlfaBiological

  • CarmustineDrug

    Also called BiCNU, BiCNUI

    Arm 1, Course 3, IV over 1 hour on day -6.

  • Cisplatin (CDDP)Drug

    Also called Platinol, Platinol-AQ

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

  • Cytarabine (ARA-C)Drug

    Also called ARA-C, Cytosar, DepotCyt, Cytosine arabinosine hydrochloride

    Arm 1, Course 3, every 12 hours on days -5 to -2.

  • Etoposide (VP-16)Drug

    Also called VePesid

    Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.

  • IdarubicinDrug

    Also called Idamycin

  • IfosfamideDrug

    Also called Ifex

    During Course 1, IV continuously; Course 2, IV continuously on days 1-3.

  • Leucovorin CalciumDrug

    Also called Leucovorin, Citrovorum, Wellcovorin

  • MelphalanDrug

    Also called Alkeran

  • MethotrexateDrug

  • MethylprednisoloneDrug

    Also called Depo-Medrol, Medrol, Solu-Medrol

  • mitoxantrone hydrochloride (DHAD)Drug

    Also called mitoxantrone, Novantrone

    Arm 1, Course 2, IV on day 1.

  • Vincristine SulfateDrug

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called autologous peripheral blood stem cells, PBSC

    Infusion of stem cells on Day 0.

  • Radiation TherapyRadiation

    Also called RT

Study groups in NCT00002835
Study groupRoleWhat they receive
Arm IExperimental3 courses of early intensification: First course: Ifosfamide (IFF) IV continuously and Etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest. Second course: IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in first course. Third course: Carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Filgrastim (G-CSF); Drug: Carmustine; Drug: Cytarabine (ARA-C); Drug: Etoposide (VP-16); Drug: Ifosfamide; Drug: Melphalan; Drug: mitoxantrone hydrochloride (DHAD); Procedure: Peripheral Blood Stem Cell Transplantation
Arm IIExperimentalIDSHAP during 4 week courses 2 and 5, MBIDCOS during courses 3 and 6, and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1, 4, and 7.
Receives: Biological: Bleomycin Sulfate (BLM); Biological: Recombinant Interferon Alfa; Drug: Cisplatin (CDDP); Drug: Cyclophosphamide; Drug: Idarubicin; Drug: Leucovorin Calcium; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Vincristine Sulfate; Procedure: Peripheral Blood Stem Cell Transplantation; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Early Intensification vs. Alternating Triple Chemotherapy

    Measured: Monthly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2003 (estimated)
  2. Study start30 Oct 1995
  3. Primary completion4 Feb 2004
  4. Study completion4 Feb 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002835
Sponsor's protocol ID
MDA DM95-121
Other IDs
P30CA016672, MDA-DM-95121, NCI-V96-1010, CDR0000065044
Status last verified
Nov 2018
First submitted
1 Nov 1999
Last updated
15 Nov 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bleomycin Sulfate (BLM), Filgrastim (G-CSF) and Recombinant Interferon Alfa in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Early Intensification vs. Alternating Triple Chemotherapy (time frame: Monthly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

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