Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

July 1, 2010

Primary Completion Date

December 15, 2022

Study Completion Date

December 31, 2027

Conditions
Hairy Cell Leukemia
Interventions
DRUG

Pentostatin

28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle.

DRUG

Rituximab

Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

DRUG

Bendamustine

1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle

DRUG

Acetaminophen

Treatment of infusion-related symptoms with acetaminophen is recommended.

DRUG

Diphenhydramine

Treatment of infusion-related symptoms with diphenhydramine is recommended.

DRUG

Epinephrine

Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.

DRUG

Antihistamines

Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.

DRUG

Corticosteroids

Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.

DRUG

Bronchodilators

Additional treatment with bronchodilators may be indicated.

OTHER

Intravenous (IV) Saline

Additional treatment with intravenous (IV) saline may be indicated.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH