65 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients With Complete Response (CR)Primary· Assessed after 2 cycles of treatment and 2 months after completion of therapy
Response was evaluated using NCI-WG96 criteria.
A CR requires all of the following for \>= 2 months:
* Absence of lymphadenopathy \> 1 cm in diameter by physical examination
* No hepatomegaly or splenomegaly on physical exam
* No constitutional symptoms
* Normal complete blood count (CBC)
* Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidence of residual disease and no radiological evidence of residual CLL on CT scan of chest-abdomen-pelvi
Group
Value
95% CI
Arm A (Standard Dose)
0.5
0.247 – 0.753
Arm B (Low Dose)
0.4
0.163 – 0.677
Proportion of Patients With Overall Response (OR)Primary· Assessed after 2 cycles of treatment and 2 months after completion of therapy
OR is defined as either CR, clinical CR, or partial response (PR) evaluated by NCI-WG96 criteria. CR has been defined in the other primary endpoint.
A clinical CR requires all of the following:
* Absence of lymphadenopathy by physical examination
* No hepatomegaly or splenomegaly. Spleen and/or liver, if considered enlarged at baseline, should not be palpable, due to disease, on physical exam
* Absence of constitutional symptoms
* Normal CBC as exhibited by:
A PR requires all the following for ≥2 months:
* ≥50% decrease in peripheral blood lymphocyte count from baseline
* ≥50% reduction in
Group
Value
95% CI
Arm A (Standard Dose)
0.875
0.617 – 0.985
Arm B (Low Dose)
0.933
0.681 – 0.998
Overall Survival (OS)Secondary· Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years
OS is defined to be time from randomization to death from any cause. Those still alive are censored at the date of last contact.
Group
Value
95% CI
Arm A (Standard Dose)
NA
22.3 – NA
Arm B (Low Dose)
NA
32.8 – NA
Progression-free Survival (PFS)Secondary· Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years
PFS is defined to be time from randomization to progression (PD) or to death without documentation of progression. For patients without PD, follow-up is censored at the date of last disease assessment without PD, unless death occurs within three months following the date last known progression free.
PD is characterized by at least one of the following:
* ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart (at least 1 node must be \>2 cm). Appearance of new palpable lymph nodes (\>1 cm in diameter).
* ≥50% increase in the size of live
Group
Value
95% CI
Arm A (Standard Dose)
12.8
11.7 – NA
Arm B (Low Dose)
23.3
14.8 – NA
Time to ResponseSecondary· Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years
Time to response is defined to be time from randomization to first confirmed CR, PR or clinical CR. Those without confirmed CR, PR or clinical CR are censored at the date of last disease assessment.
Group
Value
95% CI
Arm A (Standard Dose)
4.8
4.6 – 5.7
Arm B (Low Dose)
4.7
2.7 – 6.5
Duration of ResponseSecondary· Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years
Duration of response is defined to be time from first confirmed CR, PR or clinical CR to progression or to death without documentation of progression. Patients without confirmed CR, PR or clinical CR are censored at time 0. Those without documentation of progression are censored at the date of last disease assessment without progression, unless death occurs within three months following the date last known progression free.
Group
Value
95% CI
Arm A (Standard Dose)
9.8
7.7 – NA
Arm B (Low Dose)
16.8
10.1 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab together with alemtuzumab may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03504241 — Tolerance by Engaging Antigen During Cellular Homeostasis
· Phase 1
· completed
NCT02689453 — Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and A
· Phase 1
· completed
NCT01625351 — A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumor
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group
Last refreshed: 28 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01013961.