Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia

Browse trials for

• Leukemia, Lymphocytic, Chronic, B-Cell 1,648
• Leukemia 5,475
• Bronchiolitis Obliterans Syndrome 389
• Recurrence 4,347

Keywords

• CAMPATH
• Alemtuzumab
• Leukemia
• MabCampath
• Chronic
• Subcutaneous
• CLL
• C-CLL
• Relapsed
• Refractory
• Chronic Lymphocytic Leukemia

Leukemia, Lymphocytic, Chronic, B-Cell

1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.

This study's enrollment of 86 is above the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 308 studies on the registry; 5 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 19 (76%) have results posted.

First submitted before Genzyme became part of Sanofi.

Study arms

• Experimental
  Dose escalation

  Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated).

  Biological: Alemtuzumab

• Experimental
  No escalation

  Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered subcutaneously at alternating injection sites 3 times per week for up to 18 weeks.

  Biological: Alemtuzumab

Interventions

• BiologicalAlemtuzumab

  Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks. Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study.

  Also known as: Campath®, MabCampath®

• BiologicalAlemtuzumab

  Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks. Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration.

  Also known as: Campath®, MabCampath®

Primary outcomes

1. Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)

   Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.

   Time frame: up to 44 weeks

2. Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)

   Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.

   Time frame: up to 44 weeks

Secondary outcomes

1. Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)

   Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months. Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

   Time frame: up to 5 years

2. Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)

   Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months. Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

   Time frame: up to 5 years

3. Kaplan-Meier Estimates of Overall Survival

   Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.

   Time frame: up to 5 years

4. Participants With a Minimal Residual Disease (MRD) Status of Negative

   MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.

   Time frame: 44 weeks

5. Participants With Treatment-Emergent Adverse Events (TEAE)

   Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.

   Time frame: up to 18 weeks of treatment plus 45 days

Baseline characteristics