Leukemias, lymphomas, and other hematologic cancers:

Indications for: Fludarabine

B-cell chronic lymphocytic leukemia (CLL) in patients who have not responded to or whose disease progressed during treatment with at least 1 alkylating-agent containing regimen.

Clinical Trials:

Two single-arm open-label studies of fludarabine phosphate for injection have been conducted in adult patients with CLL refractory to at least one prior standard alkylating-agent containing regimen. 

In a study conducted by MD Anderson Cancer Center (MDAH), 48 patients were treated with a dose of 22-40 mg/m2 daily for 5 days every 28 days. Another study conducted by the Southwest Oncology Group (SWOG) involved 31 patients treated with a dose of 15-25 mg/m2 daily for 5 days every 28 days. 

The overall objective response rates were 48% and 32% in the MDAH and SWOG studies, respectively. The complete response rate in both studies was 13%; the partial response rate was 35% in the MDAH study and 19% in the SWOG study. These response rates were obtained using standardized response criteria developed by the National Cancer Institute CLL Working Group 3 and were achieved in heavily pretreated patients. 

The median time to response in the MDAH and SWOG studies was 7 weeks (range of 1-68 weeks) and 21 weeks (range of 1-53 weeks) respectively. The median duration of disease control was 91 weeks (MDAH) and 65 weeks (SWOG). The median survival of all refractory CLL patients treated with fludarabine phosphate for injection was 43 weeks and 52 weeks in the MDAH and SWOG studies, respectively.

Rai stage improved to Stage II or better in 7 of 12 MDAH responders (58%) and in 5 of 7 SWOG responders (71%) who were Stage III or IV at baseline. In the combined studies, mean hemoglobin concentration improved from 9.0 g/dL at baseline to 11.8 g/dL at the time of response in a subgroup of anemic patients. Similarly, average platelet count improved from 63,500/mm3 to 103,300/mm3 at the time of response in a subgroup of patients who were thrombocytopenic at baseline.

Adult Dosage:

Give by IV infusion over 30 minutes. 25mg/m2 daily for 5 days every 28 days. Renal dysfunction (CrCl 30–70mL/min): reduce dose by 20%; CrCl <30mL/min: not recommended. Give for 3 cycles after the max response. Reduce or delay dose if toxicity occurs.

Children Dosage:

Not recommended.

Boxed Warning:

Severe bone marrow suppression. CNS toxicity. Hemolytic anemia. Pulmonary toxicity.

Fludarabine Warnings/Precautions:

Myelosuppression. Evaluate and monitor for hemolysis. Monitor blood (esp CBC, platelets). Use irradiated blood products if transfusions are required. May need to prophylax for tumor lysis syndrome with large tumors. Renal insufficiency. Delay or stop therapy if neurotoxicity occurs. Elderly. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Fludarabine Classification:


Fludarabine Interactions:

Severe pulmonary toxicity with pentostatin (not recommended).

Adverse Reactions:

Myelosuppression (severe/cumulative), bone marrow hypoplasia, autoimmune hemolytic anemia (fatal/severe), infection, fever, chills, GI upset, malaise, fatigue, CNS effects (eg, weakness, agitation, confusion, visual disturbances, coma, peripheral neuropathy), pneumonia, pulmonary hypersensitivity (eg, dyspnea, interstitial pulmonary infiltrate), stomatitis, GI bleeding, edema, tumor lysis syndrome, rash, hemorrhagic cystitis (rare); others.


Formerly known under the brand name Fludara.


Fludarabine phosphate is rapidly dephosphorylated to the active metabolite, 2-fluoro-ara-A, within minutes after intravenous infusion.

Drug Elimination:

The terminal half-life of 2-fluoro-ara-A was ~20 hours. 

How Supplied:

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