CLLPhase 2CRC027NCT01191190
Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Ofatumumab/HDMP in people with CLL, run by Januario Castro, M.D. at 2 sites in United States.
Trial summary
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL
- What is being tested?
- Ofatumumab/HDMP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously treated patients with a diagnosis of CLL
- Previous treatment with any monoclonal antibody or chemotherapy regardless of response as defined by the iwCLL Working Group Guidelines as evidenced by:
- progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
- massive nodes (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
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- autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy (See Section 10.2)
- Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: unintentional weight loss of 10% or more within the previous 6 months significant fatigue (i.e. ECOG PS 2 or worse, inability to work or perform usual activities), fevers higher than 100.5ºF or 38.0ºC for 2 or more weeks without other evidence of infection, night sweats for more than 1 month without evidence of infection
- Subjects must be 18 years of age or older, male or female.
- ECOG performance status of 0-2.
- Subjects must be able to give informed consent.
- Females of child bearing potential(FCBP)† must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of starting treatment and agree to use a medically accepted contraceptive method for the duration of this study.
Who cannot join
- Hepatitis BsAg positive, Hepatitis BcAb positive, and Hepatitis C positive patients.
- Known HIV positive patients.
- Diabetics.
- Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).
- Screening laboratory values within these ranges: platelets <50 x 109/L, neutrophils <1.0 x 109/L, creatinine >2.0 times upper normal limit,total bilirubin >1.5 times upper normal limit (unless a known history of Gilbert's disease), ALT >2.5 times upper normal limit (unless due to disease involvement of liver), alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
- Inability to provide informed consent.
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- Concurrent malignancy (excluding basal and squamous cell skin cancers).
- Active fungal, bacterial, and/or viral infection.
- History of peptic ulcer disease resulting in GI bleeding within the last 6 months.
- Untreated metabolic disorders such as hypothyroidism and Cushing's disease.
- History of steroid-induced psychosis.
- Estimated life expectancy of less than 3 months by the investigator's best clinical judgment.
- Serious medical condition that would render the subject medically unstable.
- Women who are pregnant or breast-feeding.
- History of Pancreatitis.
- History of Diverticulitis.
- Patients with known hypersensitivity to ofatumumab or known history of anaphylaxis to Rituximab or alemtuzumab.
- Concurrent use of other anti-cancer agents or treatments.
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of California San Diego, Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: A Phase II Study of Ofatumumab in Combination With High-dose Methylprednisolone in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis.
Read the detailed description
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Cycles 1-3 will be administered without scheduled interruption every 28 days for a total of 12 weeks of therapy. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis. Blood glucose levels will be monitored immediately after HDMP infusion by finger stick glucometry. Two months following completion of treatment a response assessment will occur per iwCLL guidelines. The treatment will be administered as outpatient, and each cycle will be four weeks in duration.
- Conditions
- CLL
- Being tested
- Ofatumumab/HDMP
- Keywords
- Leukemia, Chronic leukemia, Chronic Lymphocytic Leukemia, Relapsed, Refractory
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ofatumumab/HDMPDrug
Also called Arzerra, HuMax-CD20
High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab/HDMP | Experimental | High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity. Receives: Drug: Ofatumumab/HDMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
IwCLL-WG Defined Complete Response (CR)
Responses were assessed two months after completion of therapy.
Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR.
iwCLL-WG Complete Response is defined as:
- Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L).
- Absence of lymphadenopathy (>1.5 cm)of physical exam; AND
- No hepatomegaly and splenomegaly on physical exam; AND
- Absence of constitutional symptoms; AND
- Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets > 100,000/μl, hemoglobin > 11.0g/dL (non-transfused), and lymphocyte count < 5,000/μl; AND
- Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent
Measured: 2 months
Secondary outcomes (9)
IwCLL-WG Defined Overall Response Rate (ORR)
Responses were assessed two months after completion of therapy. Overall Response Rate (ORR) = CR + PR
Measured: 2 months
IwCLL-WG Defined Nodular Partial Response (PR)
Responses were assessed two months after completion of therapy.
Partial Response is defined as:
- Greater than or equal to 50% decrease in blood absolute lymphocyte count from pre-treatment value; AND
- Greater than or equal to 50% reduction in lymphadenopathy from pre-treatment value; AND
- Greater than or equal to 50% reduction in splenomegaly/hepatomegaly from pre-treatment value.
In addition, patients need to have at least ONE of the following:
- Neutrophils ≥ 1,500/μl or ≥ 50% improvement from pre-treatment value; AND / OR
- Platelets > 100,000/μl or 50% improvement from pre-treatment value; AND / OR
- Hemoglobin > 11.0 gm/dl (non-transfused) or 50% improvement from pre-treatment value.
Measured: 2 months
IwCLL-WG Defined Partial Response (PR)
Responses were assessed two months after completion of therapy
Measured: 2 months
IwCLL-WG Defined Stable Disease (SD)
Responses were assessed two months after completion of therapy.
Subjects who do not fulfill the criteria for complete or partial response as defined above but do not exhibit progressive disease will be considered as having stable disease.
Measured: 2 months
IwCLL-WG Defined Progressive Disease (PD)
Responses were assessed two months after completion of therapy
Progressive Disease is defined as:
- Greater than or equal to 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be ≥ 2 cm; or the appearance of a new palpable lymph node; OR
- Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margins; or appearance of palpable hepatomegaly or splenomegaly, which was not previously present; OR
- Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5,000μl; OR
- Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with ≥ 56% prolymphocytes);
Measured: 2 months
Progression-free Survival (PFS)
Measured: 2 years
Treatment-Free Survival
Measured: 2 years
Safety and Tolerability Measured Via Adverse Events
Please see Adverse Event module for additional details.
Measured: 2 years
Detectable Minimal Residual Disease (MRD)
The patient who achieved a CR did not have detectable MRD in the bone marrow by four-color flow cytometry (<0.1% of cells).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CLLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Januario Castro, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Januario Castro, M.D., University of California, San Diego
- Investigators
- Januario Castro, MD, Principal investigator, University of California, San DiegoThomas J Kipps, MD, PhD, Principal investigator, Director of the CLL Research Consortium and University of California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191190
- Sponsor's protocol ID
- 100429
- Acronym
- CRC027
- Status last verified
- Apr 2018
- First submitted
- 26 Aug 2010
- Last updated
- 8 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Castro JE, James DF, Sandoval-Sus JD, Jain S, Bole J, Rassenti L, Kipps TJ. Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia. Leukemia. 2009 Oct;23(10):1779-89. doi: 10.1038/leu.2009.133. Epub 2009 Aug 20.
PubMed 19693094Castro JE, Sandoval-Sus JD, Bole J, Rassenti L, Kipps TJ. Rituximab in combination with high-dose methylprednisolone for the treatment of fludarabine refractory high-risk chronic lymphocytic leukemia. Leukemia. 2008 Nov;22(11):2048-53. doi: 10.1038/leu.2008.214. Epub 2008 Aug 28.
PubMed 18754025
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Ofatumumab in Combination With High-dose Methylprednisolone in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT01191190
- Acronym / sponsor ID
- CRC027 / 100429
- Conditions
- CLL
- Keywords
- Leukemia, Chronic leukemia, Chronic Lymphocytic Leukemia, Relapsed, Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Januario Castro, M.D.University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis.
Detailed description
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Cycles 1-3 will be administered without scheduled interruption every 28 days for a total of 12 weeks of therapy. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis. Blood glucose levels will be monitored immediately after HDMP infusion by finger stick glucometry. Two months following completion of treatment a response assessment will occur per iwCLL guidelines. The treatment will be administered as outpatient, and each cycle will be four weeks in duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab/HDMP | Experimental | Drug: Ofatumumab/HDMPHigh dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle. Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered. Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Previously treated patients with a diagnosis of CLL
- Previous treatment with any monoclonal antibody or chemotherapy regardless of response as defined by the iwCLL Working Group Guidelines as evidenced by:
- Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: unintentional weight loss of 10% or more within the previous 6 months significant fatigue (i.e. ECOG PS 2 or worse, inability to work or perform usual activities), fevers higher than 100.5ºF or 38.0ºC for 2 or more weeks without other evidence of infection, night sweats for more than 1 month without evidence of infection
- Subjects must be 18 years of age or older, male or female.
- ECOG performance status of 0-2.
Key exclusion criteria (19 listed)
- Hepatitis BsAg positive, Hepatitis BcAb positive, and Hepatitis C positive patients.
- Known HIV positive patients.
- Diabetics.
- Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).
- Screening laboratory values within these ranges: platelets <50 x 109/L, neutrophils <1.0 x 109/L, creatinine >2.0 times upper normal limit,total bilirubin >1.5 times upper normal limit (unless a known history of Gilbert's disease), ALT >2.5 times upper normal limit (unless due to disease involvement of liver), alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ofatumumab/HDMPAlso: Arzerra, HuMax-CD20High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle. Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule. Each patient will receive a maximum of 3 cycles (one cycle is 28 days) | Drug | Ofatumumab/HDMP |
Primary outcome
IwCLL-WG Defined Complete Response (CR)
Time frame: 2 months
Responses were assessed two months after completion of therapy. Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR. iwCLL-WG Complete Response is defined as: * Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L). * Absence of lymphadenopathy (>1.5 cm)of physical exam; AND * No hepatomegaly and splenomegaly on physical exam; AND * Absence of constitutional symptoms; AND * Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets > 100,000/μl, hemoglobin > 11.0g/dL (non-transfused), and lymphocyte count < 5,000/μl; AND * Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent
9 secondary outcomes
IwCLL-WG Defined Overall Response Rate (ORR)
Time frame: 2 months
IwCLL-WG Defined Nodular Partial Response (PR)
Time frame: 2 months
IwCLL-WG Defined Partial Response (PR)
Time frame: 2 months
IwCLL-WG Defined Stable Disease (SD)
Time frame: 2 months
IwCLL-WG Defined Progressive Disease (PD)
Time frame: 2 months
Progression-free Survival (PFS)
Time frame: 2 years
Treatment-Free Survival
Time frame: 2 years
Safety and Tolerability Measured Via Adverse Events
Time frame: 2 years
Detectable Minimal Residual Disease (MRD)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19693094Castro JE, James DF, Sandoval-Sus JD, Jain S, Bole J, Rassenti L, Kipps TJ. Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia. Leukemia. 2009 Oct;23(10):1779-89. doi: 10.1038/leu.2009.133. Epub 2009 Aug 20.
- Background: PubMed 18754025Castro JE, Sandoval-Sus JD, Bole J, Rassenti L, Kipps TJ. Rituximab in combination with high-dose methylprednisolone for the treatment of fludarabine refractory high-risk chronic lymphocytic leukemia. Leukemia. 2008 Nov;22(11):2048-53. doi: 10.1038/leu.2008.214. Epub 2008 Aug 28.
- Moore's UCSD Cancer CenterLink provided by the sponsor.
- Website for the Chronic Lymphocytic Leukemia Research ConsortiumLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Januario Castro, MD principal investigator
University of California, San Diego
Thomas J Kipps, MD, PhD principal investigator
Director of the CLL Research Consortium and University of California San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ofatumumab/HDMP in people with CLL, run by Januario Castro, M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IwCLL-WG Defined Complete Response (CR) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191190, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.