A Phase 2 interventional study of KW-0761 and Pralatrexate in Adult T-cell Leukemia-Lymphoma, sponsored by Kyowa Kirin, Inc.. Completed at 20 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Kyowa Kirin, Inc. · Phase 2, Interventional, and Treatment
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Among 20 studies in Leukemia-Lymphoma, Adult T-Cell with a site in United States — 3 open to participants now, 5 under way, none of them phase 3. Leukemia-Lymphoma, Adult T-Cell · United States.
Among the 20 studies in Leukemia-Lymphoma, Adult T-Cell with a site in United States, this one is the 4th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2012, is one of 6 in phase 2, and was the 9th registered.
31 studies on the registry are indexed under Leukemia-Lymphoma, Adult T-Cell; 5 are open to participants now.
Browse Leukemia-Lymphoma, Adult T-Cell studies →3 of the 20 studies in Leukemia-Lymphoma, Adult T-Cell with a site in United States are open now. Recruiting first, the newest first:
Kyowa Kirin, Inc. · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States, Jamaica
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Leukemia-Lymphoma, Adult T-Cell studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 10 · Phase 4 1
First in 1999; this study’s year is marked. 3 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 71 is above the median of 27 across 26 interventional studies indexed under Leukemia-Lymphoma, Adult T-Cell.
Median enrollment 19 across the 15 interventional studies, 500 across the 5 observational. Of the 14 that completed or were terminated, 10 (71%) have results posted.
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8 of 20 have an industry lead sponsor. The 10 most frequent:
This study is registered under Kyowa Kirin, Inc., one of the names counted as Kyowa Kirin Co., Ltd.. Under that name alone:
Kyowa Kirin, Inc. is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Kyowa Kirin Co., Ltd. has 5 studies filed under Leukemia-Lymphoma, Adult T-Cell — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Leukemia-Lymphoma, Adult T-Cell with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).
CCR4 expression in ATL patients has been demonstrated to be very high and has been associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides and Sézary syndrome. The objective of this study is to estimate the overall response rate of KW-0761 for subjects with relapsed or refractory ATL.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must currently have evidence of disease in at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
Biological: KW-0761
Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
Drug: Pralatrexate · Drug: gemcitabine plus oxaliplatin · Drug: DHAP
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Also known as: mogamulizumab, POTELIGEO®
30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
Also known as: Folotyn
Drug pages: Gemcitabine · Oxaliplatin
gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
Also known as: Gemzar, Eloxatin, GemOx
Drug pages: Dexamethasone · Cytarabine · Cisplatin
dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression
Also known as: Decadron, Dexasone, Baycadron, Platinol, Depocyt, Ara-C
Overall Response Rate
Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = \> 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment. Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment.
Time frame: every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Progression Free Survival
Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.
Time frame: From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months
Overall Survival
The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group.
Time frame: up to 36 months
Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score
The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General \[FACT-G\]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.
Time frame: From date of randomization until the date of first documented progression, up to 36 months
| Milestone | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 |
|---|---|---|---|
| Started | 47 | 24 | 0 |
| Completed | 47 | 24 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 |
|---|---|---|---|
| Started | 0 | 0 | 18 |
| Completed | 0 | 0 | 18 |
| Not completed | 0 | 0 | 0 |
Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = \> 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment. Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment.
| participants | KW-0761 | Investigator's Choice |
|---|---|---|
| Complete Response | 2 | 0 |
| Uncertified Complete Response | 0 | 0 |
| Partial Response | 11 | 2 |
| Stable Disease | 0 | 4 |
| Relapsed Disease or Progressive Disease | 16 | 13 |
| Not Assessable | 18 | 5 |
| Overall Response Rate (Confirmed and Unconfirmed) | 13 | 2 |
| Overall Response Rate Confirmed | 5 | 0 |
Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.
| percentage of subjects | KW-0761 | Investigator's Choice |
|---|---|---|
| PFS Subjects (%) Alive for at Least: 1 Month | 47.5 (31.6 to 61.9) | 44.1 (22.8 to 63.4) |
| PFS Subjects (%) Alive for at Least: 2 Months | 29.8 (16.6 to 44.2) | 33.0 (14.2 to 53.3) |
| PFS Subjects (%) Alive for at Least: 3 Months | 24.4 (12.4 to 38.5) | 26.4 (9.4 to 47.3) |
| PFS Subjects (%) Alive for at Least: 4 Months | 18.3 (7.9 to 32.1) | 13.2 (2.4 to 33.5) |
| PFS Subjects (%) Alive for at Least: 5 Months | 18.3 (7.9 to 32.1) | 0 (0 to 0) |
| PFS Subjects (%) Alive for at Least: 6 Months | 12.2 (4.0 to 25.1) | 0 (0 to 0) |
The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group.
| percentage of subjects | KW-0761 | Investigator's Choice |
|---|---|---|
| Subjects (%) Alive for at Least: 1 Month | 87.0 (73.2 to 93.9) | 91.7 (70.6 to 97.8) |
| Subjects (%) Alive for at Least: 2 Months | 75.6 (60.3 to 85.7) | 79.2 (57.0 to 90.8) |
| Subjects (%) Alive for at Least: 3 Months | 59.1 (43.1 to 72.0) | 70.8 (48.4 to 84.9) |
| Subjects (%) Alive for at Least: 4 Months | 54.3 (38.5 to 67.7) | 66.7 (44.3 to 81.7) |
| Subjects (%) Alive for at Least: 5 Months | 49.5 (33.9 to 63.3) | 54.2 (32.7 to 71.4) |
| Subjects (%) Alive for at Least: 6 Months | 44.3 (29.1 to 58.5) | 54.2 (32.7 to 71.4) |
The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General \[FACT-G\]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.
| Units on a scale | KW-0761 | Investigator's Choice |
|---|---|---|
| Baseline | 110.1 ± 22.15 | 106.8 ± 25.84 |
| Last Observation Change from Baseline | -12.1 ± 25.60 | -14.9 ± 25.56 |
Collected over From pre-treatment visit until 90 days after the last dose, approximately three months overall. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KW-0761 | 10/47 (21.3%) | 26/47 (55.3%) | 45/47 (95.7%) |
| Investigator's Choice | 1/24 (4.2%) | 10/24 (41.7%) | 24/24 (100%) |
| IC Original Then Crossover to KW-0761 | 12/18 (66.7%) | 9/18 (50%) | 17/18 (94.4%) |
| Event | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 |
|---|---|---|---|
| HypercalcaemiaMetabolism and nutrition disorders | 7/47 | 4/24 | 2/18 |
| Lactic AcidosisMetabolism and nutrition disorders | 0/47 | 0/24 | 2/18 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/47 | 2/24 | 0/18 |
| PneumoniaInfections and infestations | 3/47 | 0/24 | 0/18 |
| Acute Coronary SyndromeCardiac disorders | 0/47 | 0/24 | 1/18 |
| AstheniaGeneral disorders | 1/47 | 0/24 | 1/18 |
| FatigueGeneral disorders | 1/47 | 0/24 | 1/18 |
| Multi-Organ FailureGeneral disorders | 2/47 | 0/24 | 1/18 |
| Cytomegalovirus InfectionInfections and infestations | 0/47 | 0/24 | 1/18 |
| SepsisInfections and infestations | 2/47 | 0/24 | 1/18 |
| Event | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 |
|---|---|---|---|
| Infusion Related ReactionInjury, poisoning and procedural complications | 21/47 | 0/24 | 8/18 |
| NauseaGastrointestinal disorders | 6/47 | 9/24 | 0/18 |
| AnaemiaBlood and lymphatic system disorders | 10/47 | 3/24 | 6/18 |
| DiarrhoeaGastrointestinal disorders | 3/47 | 7/24 | 2/18 |
| VomitingGastrointestinal disorders | 4/47 | 7/24 | 1/18 |
| HeadacheNervous system disorders | 4/47 | 7/24 | 0/18 |
| PyrexiaGeneral disorders | 4/47 | 6/24 | 3/18 |
| HypomagnesaemiaMetabolism and nutrition disorders | 4/47 | 3/24 | 4/18 |
| Drug EruptionSkin and subcutaneous tissue disorders | 9/47 | 0/24 | 4/18 |
| ConstipationGastrointestinal disorders | 6/47 | 5/24 | 1/18 |
| Age, Categorical(Participants) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 22 | 57 |
| >=65 years | 12 | 2 | 14 |
| Age, Continuous(years) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| Mean | 55 (22 to 82) | 49 (24 to 80) | 53 (22 to 82) |
| Sex: Female, Male(Participants) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| Female | 23 | 14 | 37 |
| Male | 24 | 10 | 34 |
| Ethnicity (NIH/OMB)(Participants) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 6 | 15 |
| Not Hispanic or Latino | 31 | 14 | 45 |
| Unknown or Not Reported | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| Race — White | 6 | 5 | 11 |
| Race — Asian | 2 | 1 | 3 |
| Race — Black or African American | 32 | 15 | 47 |
| Race — Other | 1 | 0 | 1 |
| Race — Not Applicable | 6 | 3 | 9 |
| Region of Enrollment(participants) | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| United States | 25 | 14 | 39 |
| Brazil | 3 | 0 | 3 |
| United Kingdom | 9 | 4 | 13 |
| France | 6 | 3 | 9 |
| Peru | 4 | 3 | 7 |
The record gives a start of Jun 2012, a primary completion of Aug 2015 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2018, 2 years 10 months after primary completion. A results delay was requested in Jun 2016.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mogamulizumab
Leukemia-Lymphoma, Adult T-Cell →