Clinical trial · Interventional

Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT00193466CI-TRIAL-00004244completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

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
Non-Hodgkins Lymphoma	Non-Hodgkin Lymphoma	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
CAMPTH-1H	Drug	—	UNRESOLVED
Fludarabine	Drug	Fludarabine	ALIAS
Rituximab	Drug	Rituximab	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Complete response rate

Secondary outcomes (3)

measure
Molecular complete response rate
measure
Progression free survival
measure
Overall toxicity

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically proven B-cell CLL/SLL
* Positive staining for CD20 antigen
* No systemic chemotherapy.
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Age \> 18 years
* Life expectancy \> 12 weeks
* Adequate liver and kidney function
* Must be accessible for treatment and follow-up
* Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Female pregnant or lactating
* Unstabilized active infection on the basis of neutropenia
* History of previous severe opportunistic infections
* Serious underlying medical conditions
* Central nervous system involvement
* History of other neoplasms, either active or treated within five years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

References

Publications (1)

RESULTHainsworth JD, Vazquez ER, Spigel DR, Raefsky E, Bearden JD, Saez RA, Greco FA. Combination therapy with fludarabine and rituximab followed by alemtuzumab in the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Mar 15;112(6):1288-95. doi: 10.1002/cncr.23271. PMID 18189296