Clinical trial · Interventional

Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkin's Lymphoma

NCT00052936CI-TRIAL-00051864completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
CHOP regimen	Drug	CHOP Regimen	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
prednisone	Drug	Prednisone	ALIAS
radiation therapy	Radiation	—	UNRESOLVED
rituximab	Biological	Rituximab	ALIAS
vincristine sulfate	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
S6
description
6x CHOP-14
interventionNames
1. Biological: filgrastim
2. Drug: CHOP regimen
3. Drug: cyclophosphamide
4. Drug: doxorubicin hydrochloride
5. Drug: prednisone
6. Drug: vincristine sulfate
7. Radiation: radiation therapy
type
EXPERIMENTAL
label
R6
description
6x CHOP-14 + 8x Rituximab
interventionNames
1. Biological: filgrastim
2. Biological: rituximab
3. Drug: CHOP regimen
4. Drug: cyclophosphamide
5. Drug: doxorubicin hydrochloride
6. Drug: prednisone
7. Drug: vincristine sulfate

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 61 Years
Maximum age: 80 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
* CD20\^+ B-cell lymphoma or CD20\^- B-cell and T-cell lymphoma allowed
* B-cell NHL including the following:

  * Stage III follicular lymphoma
  * Stage III follicular lymphoma and diffuse B-cell lymphoma
  * Lymphoblastic precursor B-cell lymphoma
  * Diffuse large cell B-cell lymphoma

    * Centroblastic
    * Immunoblastic
    * Plasmablastic
    * Anaplastic large cell
    * T-cell-rich B-cell lymphoma
    * Primary effusion lymphoma
    * Intravasal B-cell lymphoma
    * Primary mediastinal B-cell lymphoma
  * Mantle zone lymphoma, blastoid
  * Burkitt's lymphoma
  * Burkitt-like lymphoma
  * Aggressive marginal zone lymphoma (monocytoid)
* T-cell NHL including the following:

  * Lymphoblastic precursor T-cell lymphoma
  * Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS)

    * Lennert's lymphoma
    * T-zone lymphoma
  * T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type
  * Anaplastic large cell lymphoma

    * ALK\^+
    * ALK\^-
  * Extranodal NK/T-cell lymphoma, nasal type
  * Intestinal T/NK-cell lymphoma (with or without enteropathy)

    * Hepatosplenic gamma-delta lymphoma
    * Subcutaneous panniculitis-like PTCL
    * Aggressive T/NK PTCL
  * Anaplastic large-cell NHL, NOS
* Bone marrow involvement no more than 25%
* No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract

PATIENT CHARACTERISTICS:

Age

* 61 to 80

Performance status

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 2,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* No active hepatitis infection

Renal

* Creatinine no greater than 2 times ULN

Cardiovascular

* No Canadian Cardiovascular Society class III or IV angina pectoris
* No New York Heart Association class III or IV cardiac failure
* Ejection fraction at least 50%
* Fractional shortenings at least 25% by echocardiography or nuclear medicine examination

Pulmonary

* FEV1 at least 50%
* Diffusion capacity at least 50%

Other

* No uncontrolled diabetes mellitus
* No known hypersensitivity to any study medications
* No other concurrent malignancy
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified

Other

* Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study)
* No other concurrent lymphoma therapy
* No concurrent participation in another treatment study

References

Publications (8)

RESULTPfreundschuh M, Schubert J, Ziepert M, Schmits R, Mohren M, Lengfelder E, Reiser M, Nickenig C, Clemens M, Peter N, Bokemeyer C, Eimermacher H, Ho A, Hoffmann M, Mertelsmann R, Trumper L, Balleisen L, Liersch R, Metzner B, Hartmann F, Glass B, Poeschel V, Schmitz N, Ruebe C, Feller AC, Loeffler M; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008 Feb;9(2):105-16. doi: 10.1016/S1470-2045(08)70002-0. Epub 2008 Jan 15. PMID 18226581
DERIVEDChristofyllakis K, Kaddu-Mulindwa D, Lesan V, Rixecker T, Kos IA, Held G, Regitz E, Pfreundschuh M, Bittenbring JT, Thurner L, Poeschel V, Ziepert M, Altmann B, Bewarder M. An inherited genetic variant of the CEP72 gene is associated with the development of vincristine-induced peripheral neuropathy in female patients with aggressive B-cell lymphoma. Ann Hematol. 2024 Nov;103(11):4599-4606. doi: 10.1007/s00277-024-05973-9. Epub 2024 Sep 4. PMID 39227453
DERIVEDKuhnl A, Cunningham D, Counsell N, Hawkes EA, Qian W, Smith P, Chadwick N, Lawrie A, Mouncey P, Jack A, Pocock C, Ardeshna KM, Radford J, McMillan A, Davies J, Turner D, Kruger A, Johnson PW, Gambell J, Rosenwald A, Ott G, Horn H, Ziepert M, Pfreundschuh M, Linch D. Outcome of elderly patients with diffuse large B-cell lymphoma treated with R-CHOP: results from the UK NCRI R-CHOP14v21 trial with combined analysis of molecular characteristics with the DSHNHL RICOVER-60 trial. Ann Oncol. 2017 Jul 1;28(7):1540-1546. doi: 10.1093/annonc/mdx128. PMID 28398499
DERIVEDPfreundschuh M, Poeschel V, Zeynalova S, Hanel M, Held G, Schmitz N, Viardot A, Dreyling MH, Hallek M, Mueller C, Wiesen MH, Witzens-Harig M, Truemper L, Keller U, Rixecker T, Zwick C, Murawski N. Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the SMARTE-R-CHOP-14 trial of the german high-grade non-Hodgkin lymphoma study group. J Clin Oncol. 2014 Dec 20;32(36):4127-33. doi: 10.1200/JCO.2013.54.6861. Epub 2014 Nov 17. PMID 25403207

Registry

Dates and enrollment

Start: Jan 1, 2001
Primary completion: Aug 5, 2010
Completion: Aug 5, 2010
First posted: Jan 27, 2003
Last update posted: May 18, 2021
Enrollment: 1,506 (actual)
Lead sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group OTHER
Keywords: anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage I adult Burkitt lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma