Adults 13 Months to 30, any sex, with Recurrent Adult Hodgkin Lymphoma or Recurrent Childhood Hodgkin Lymphoma. 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.
Maximum Tolerated Dose (MTD) for Brentuximab VedotinPrimary· During cycle 1 of protocol therapy (21 days)
MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0Primary· 13 months from first dose
The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.
Abdominal pain
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
0
Dose 1.8mg/kg (Phase I + Phase II)
1
Adrenal insufficiency
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
0
Dose 1.8mg/kg (Phase I + Phase II)
1
Alanine aminotransferase increased
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
1
Dose 1.8mg/kg (Phase I + Phase II)
13
Anemia
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
1
Dose 1.8mg/kg (Phase I + Phase II)
4
Anorexia
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
0
Dose 1.8mg/kg (Phase I + Phase II)
1
Aspartate aminotransferase increased
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
1
Dose 1.8mg/kg (Phase I + Phase II)
10
Dehydration
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
0
Dose 1.8mg/kg (Phase I + Phase II)
1
Dental caries
Group
Value
95% CI
Dose 1.4mg/kg (Phase I)
0
Dose 1.8mg/kg (Phase I + Phase II)
1
The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)Primary· After 4 cycles (21 days per cycle) of protocol therapy
The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.Secondary· Up to 13 months from first dose
The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.
Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)Secondary· After 4 cycles (21 days per cycle) of protocol therapy
The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)Secondary· From baseline to time prior to cycle 2
Limit to 41 evaluable patients who received dose 1.8 mg/kg
Baseline
Group
Value
95% CI
Dose 1.8mg/kg
5700
389 – 18,667
Prior to Cycle 2
Group
Value
95% CI
Dose 1.8mg/kg
668
6 – 9,718
Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) PolymorphismSecondary· From the end of first dose to the end of last dose (Up to 13 Months)
Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described.
Homozygous FF- Phenylalanine
Group
Value
95% CI
Dose 1.8mg/kg
22
Heterozygous FV- Valine/Phenylalanine
Group
Value
95% CI
Dose 1.8mg/kg
14
Homozygous VV- Valine
Group
Value
95% CI
Dose 1.8mg/kg
5
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose up to 13 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose1.4mg/kg
Serious: 3/3 (100%)
Deaths: 2/3
Dose 1.8mg/kg
Serious: 37/42 (88%)
Deaths: 2/42
Serious adverse events (31 terms)
Reaction
System
Dose1.4mg/kg
Dose 1.8mg/kg
Neutrophil count decreased
Investigations
—
—
White blood cell decreased
Investigations
—
—
Alanine aminotransferase increased
Investigations
—
—
Platelet count decreased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Lymphocyte count decreased
Investigations
—
—
Anemia
Blood and lymphatic system disorders
—
—
Hypotension
Vascular disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Lung infection
Infections and infestations
—
—
Hypophosphatemia
Metabolism and nutrition disorders
—
—
Hemolytic uremic syndrome
Blood and lymphatic system disorders
—
—
Pericardial effusion
Cardiac disorders
—
—
Adrenal insufficiency
Endocrine disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Dental caries
Gastrointestinal disorders
—
—
Non-cardiac chest pain
General disorders
—
—
Infections and infestations - Other- Specify
Infections and infestations
—
—
Skin infection
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
GGT increased
Investigations
—
—
Investigations - Other- Specify
Investigations
—
—
Other adverse events (100 terms — click to expand)
This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with gemcitabine hydrochloride and to see how well they work in treating younger patients with Hodgkin lymphoma that has returned or does not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT06831370 — A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
· Phase 4
· recruiting
NCT05711628 — A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Re
· Phase 3
· withdrawn
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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 National Cancer Institute (NCI)
Last refreshed: 28 October 2021
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/NCT01780662.